Trial Outcomes & Findings for Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer (NCT NCT00451555)
NCT ID: NCT00451555
Last Updated: 2019-11-01
Results Overview
Clinical benefit rate is defined as the rate of confirmed CR, confirmed PR, and SD for 24 weeks duration and is the best response CR, PR, or SD as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)
Results posted on
2019-11-01
Participant Flow
Completers include participants who had died from any cause, who discontinued due to progressive disease or were alive and on study but no longer receiving treatment at end of the study.
Participant milestones
| Measure |
Enzastaurin + Fulvestrant
(Initial Therapy) Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
(Amended Therapy) Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Enzastaurin Once Daily Dosing: Participants received Enzastaurin 500 mg QD. Enzastaurin Twice Daily Dosing: Participants received Enzastaurin 500 mg BID. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
Participants received fulvestrant: 500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
60
|
|
Overall Study
Received at Least One Dose of Study Drug
|
94
|
58
|
|
Overall Study
Enzastaurin Twice Daily Dosing (BID)
|
39
|
0
|
|
Overall Study
Enzastaurin Once Daily Dosing (QD)
|
55
|
0
|
|
Overall Study
Progressive Disease
|
75
|
54
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
COMPLETED
|
83
|
56
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
Enzastaurin + Fulvestrant
(Initial Therapy) Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
(Amended Therapy) Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Enzastaurin Once Daily Dosing: Participants received Enzastaurin 500 mg QD. Enzastaurin Twice Daily Dosing: Participants received Enzastaurin 500 mg BID. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
Participants received fulvestrant: 500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer
Baseline characteristics by cohort
| Measure |
Enzastaurin + Fulvestrant BID
n=39 Participants
Participants received Enzastaurin 1125 mg loading dose then 250 mg, oral, twice daily (BID) (for a total of 500 mg), until disease progression
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Enzastaurin + Fulvestrant QD
n=55 Participants
Participants received Enzastaurin 1125 mg loading dose then received Enzastaurin once daily (QD) regimen of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Placebo + Fulvestrant BID
n=58 Participants
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression.
Then, participants received placebo, oral, daily.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
66.5 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
65.4 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
64.9 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
152 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
151 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)Population: All randomized participants who received at least one dose of study drug.
Clinical benefit rate is defined as the rate of confirmed CR, confirmed PR, and SD for 24 weeks duration and is the best response CR, PR, or SD as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.
Outcome measures
| Measure |
Enzastaurin + Fulvestrant QD + BID
n=94 Participants
Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
.
|
Enzastaurin + Fulvestrant BID
n=39 Participants
Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Enzastaurin + Fulvestrant QD
n=55 Participants
Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
n=58 Participants
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate)
|
43.6 percentage of participants
Interval 33.4 to 54.2
|
43.6 percentage of participants
Interval 27.8 to 60.4
|
43.6 percentage of participants
Interval 30.3 to 57.7
|
44.8 percentage of participants
Interval 31.7 to 58.5
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)Population: All randomized participants who received at least one dose of study drug.
The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; SD was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. The 95% confidence interval (CI) was calculated by exact method. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints.
Outcome measures
| Measure |
Enzastaurin + Fulvestrant QD + BID
n=94 Participants
Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
.
|
Enzastaurin + Fulvestrant BID
n=39 Participants
Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Enzastaurin + Fulvestrant QD
n=55 Participants
Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
n=58 Participants
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Overall Tumor Response Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR])
|
5.3 percentage of participants
Interval 1.7 to 12.0
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
5.5 percentage of participants
Interval 1.1 to 15.1
|
5.2 percentage of participants
Interval 1.1 to 14.4
|
SECONDARY outcome
Timeframe: Time of Clinical Benefit to Progressive Disease or Death (Up to 3 Years)Population: All randomized participants who received at least one dose of study drug and had evaluable clinical benefit duration data.
The duration of clinical benefit was measured from the time of clinical benefit of CR, PR or SD to the time of progressive disease or death from any cause. PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints.
Outcome measures
| Measure |
Enzastaurin + Fulvestrant QD + BID
n=41 Participants
Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
.
|
Enzastaurin + Fulvestrant BID
n=17 Participants
Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Enzastaurin + Fulvestrant QD
n=24 Participants
Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
n=26 Participants
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|---|---|
|
Duration of Clinical Benefit
|
9.6 months
Interval 8.2 to 11.0
|
9.4 months
Interval 7.4 to 12.2
|
9.6 months
Interval 7.9 to 11.1
|
9.7 months
Interval 7.4 to 12.6
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 3 Years)Population: All randomized participants who had received at least one dose of study drug and had evaluable PFS data. Participants were censored in Fulvestrant + Enzastaurin (QD) arm = 4, the Fulvestrant + Enzastaurin (BID) arm = 6, and the Fulvestrant + Placebo arm = 6.
Progression-free survival (PFS) time was defined as the time from baseline to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.
Outcome measures
| Measure |
Enzastaurin + Fulvestrant QD + BID
n=94 Participants
Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
.
|
Enzastaurin + Fulvestrant BID
n=39 Participants
Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Enzastaurin + Fulvestrant QD
n=55 Participants
Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
n=58 Participants
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.2 months
Interval 3.5 to 7.4
|
3.7 months
Interval 2.8 to 7.4
|
6.0 months
Interval 2.8 to 7.9
|
5.5 months
Interval 3.8 to 7.4
|
SECONDARY outcome
Timeframe: From Baseline to Study Completion (Up to 3 years, 9 months)Population: All randomized participants who received at least one dose of study drug.
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. Participants who discontinued due to an AE or SAE are reported.
Outcome measures
| Measure |
Enzastaurin + Fulvestrant QD + BID
n=94 Participants
Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
.
|
Enzastaurin + Fulvestrant BID
n=39 Participants
Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Enzastaurin + Fulvestrant QD
n=55 Participants
Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
n=58 Participants
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued With Adverse Events (AE) and Serious Adverse Events (SAEs)
Adverse Events (AEs)
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Discontinued With Adverse Events (AE) and Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Cycle 2 to Study Completion (Up to 3 Years, 9 Months)Population: Zero participants were analyzed due to insufficient samples being collected.
Outcome measures
Outcome data not reported
Adverse Events
Fulvestrant + Enzastaurin (QD + BID)
Serious events: 17 serious events
Other events: 78 other events
Deaths: 0 deaths
Fulvestrant + Enzastuarin (QD)
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
Fulvestrant + Enzastuarin (BID)
Serious events: 8 serious events
Other events: 47 other events
Deaths: 0 deaths
Fulvestrant + Placebo
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fulvestrant + Enzastaurin (QD + BID)
n=94 participants at risk
Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Enzastuarin (QD)
n=39 participants at risk
Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Enzastuarin (BID)
n=55 participants at risk
Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
n=58 participants at risk
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
2/94 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Ileus
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Asthenia
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Disease progression
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Oedema peripheral
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Immune system disorders
Hypersensitivity
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Device related infection
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Nervous system disorders
Syncope
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Psychiatric disorders
Depression
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Vascular disorders
Phlebitis
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
Other adverse events
| Measure |
Fulvestrant + Enzastaurin (QD + BID)
n=94 participants at risk
Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle.
Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle.
Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Enzastuarin (QD)
n=39 participants at risk
Participants received enzastaurin (250 mg; 2 tablets) or placebo administered orally twice daily (BID) in a 28-day cycle, until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Enzastuarin (BID)
n=55 participants at risk
Participants received Enzastaurin once daily (QD) regimen consisted of enzastaurin 500 mg orally QD in a 28-day cycle until disease progression. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Ful 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
|
Fulvestrant + Placebo
n=58 participants at risk
Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
8/94 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
9.1%
5/55 • Number of events 6 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
6.9%
4/58 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
2/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
6.9%
4/58 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.5%
8/94 • Number of events 11 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
9.1%
5/55 • Number of events 6 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
6.9%
4/58 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
7/94 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.3%
4/55 • Number of events 6 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Constipation
|
18.1%
17/94 • Number of events 21 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
17.9%
7/39 • Number of events 10 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
18.2%
10/55 • Number of events 11 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.1%
7/58 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.3%
20/94 • Number of events 33 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
15.4%
6/39 • Number of events 16 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
25.5%
14/55 • Number of events 17 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
17.2%
10/58 • Number of events 12 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
3/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
4/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Faeces discoloured
|
3.2%
3/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/94 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.2%
3/58 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Nausea
|
33.0%
31/94 • Number of events 33 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
33.3%
13/39 • Number of events 13 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
32.7%
18/55 • Number of events 20 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
31.0%
18/58 • Number of events 31 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
9/94 • Number of events 10 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
10.3%
4/39 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
9.1%
5/55 • Number of events 6 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
10.3%
6/58 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Asthenia
|
16.0%
15/94 • Number of events 19 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
15.4%
6/39 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
16.4%
9/55 • Number of events 10 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
17.2%
10/58 • Number of events 11 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Chest pain
|
3.2%
3/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
8.6%
5/58 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Fatigue
|
22.3%
21/94 • Number of events 23 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
23.1%
9/39 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
21.8%
12/55 • Number of events 14 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
19.0%
11/58 • Number of events 14 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Influenza like illness
|
4.3%
4/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Malaise
|
2.1%
2/94 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Oedema peripheral
|
6.4%
6/94 • Number of events 7 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.2%
3/58 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
General disorders
Pyrexia
|
7.4%
7/94 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
10.3%
4/39 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.2%
3/58 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Bronchitis
|
4.3%
4/94 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
6.9%
4/58 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Cystitis
|
5.3%
5/94 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Infection
|
4.3%
4/94 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
5/94 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
9.1%
5/55 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Pharyngitis
|
2.1%
2/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Rhinitis
|
3.2%
3/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
6.9%
4/58 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
4/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Investigations
Electrocardiogram qt prolonged
|
3.2%
3/94 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.3%
4/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Investigations
Weight decreased
|
2.1%
2/94 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
5/94 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.2%
3/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
9/94 • Number of events 10 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
17.9%
7/39 • Number of events 7 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.1%
7/58 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
8/94 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.8%
5/39 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.1%
7/58 • Number of events 7 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.6%
9/94 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.7%
7/55 • Number of events 7 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
17.2%
10/58 • Number of events 11 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/94 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.2%
3/58 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
2/94 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
8.6%
5/58 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.2%
3/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
5/94 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
9.1%
5/55 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.2%
3/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/58 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Nervous system disorders
Dizziness
|
3.2%
3/94 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/55 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
8.6%
5/58 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Nervous system disorders
Headache
|
11.7%
11/94 • Number of events 14 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
10.3%
4/39 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.7%
7/55 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.1%
7/58 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Nervous system disorders
Paraesthesia
|
3.2%
3/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Nervous system disorders
Sciatica
|
3.2%
3/94 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Psychiatric disorders
Insomnia
|
2.1%
2/94 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.2%
3/58 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Renal and urinary disorders
Chromaturia
|
9.6%
9/94 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
10.9%
6/55 • Number of events 6 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
9/94 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.1%
2/39 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.7%
7/55 • Number of events 7 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
12.1%
7/58 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.3%
4/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.4%
2/58 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.8%
12/94 • Number of events 14 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
10.3%
4/39 • Number of events 5 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
14.5%
8/55 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
13.8%
8/58 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.1%
2/94 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
0.00%
0/39 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
3.6%
2/55 • Number of events 2 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
6.9%
4/58 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
4/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
7.7%
3/39 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.8%
1/55 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
1.7%
1/58 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
4/94 • Number of events 4 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
2.6%
1/39 • Number of events 1 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.5%
3/55 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
5.2%
3/58 • Number of events 3 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
|
Vascular disorders
Hot flush
|
14.9%
14/94 • Number of events 17 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
20.5%
8/39 • Number of events 9 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
10.9%
6/55 • Number of events 8 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
8.6%
5/58 • Number of events 7 • From Baseline to Study Completion (Up to 3 Years, 9 Months)
All randomized participants who received at least one dose of study drug in Enzastaurin and Fulvestrant administered in combination or alone.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60