Trial Outcomes & Findings for Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer (NCT NCT02953860)
NCT ID: NCT02953860
Last Updated: 2021-05-14
Results Overview
To determine the clinical benefit rate at 24 weeks of the combination of enzalutamide/fulvestrant. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or by caliper. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; clinical benefit rate (CBR) at 24 weeks (CR + PR + stable disease lasting at least 24 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
24 Weeks
Results posted on
2021-05-14
Participant Flow
Participant milestones
| Measure |
Fulvestrant With Enzalutamide
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
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|---|---|
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Overall Study
STARTED
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32
|
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Fulvestrant With Enzalutamide
n=32 Participants
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
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|---|---|
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Age, Continuous
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61 years
n=99 Participants
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Sex: Female, Male
Female
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32 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=99 Participants
|
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Race (NIH/OMB)
White
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27 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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32 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 24 WeeksPopulation: All eligible patients
To determine the clinical benefit rate at 24 weeks of the combination of enzalutamide/fulvestrant. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or by caliper. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; clinical benefit rate (CBR) at 24 weeks (CR + PR + stable disease lasting at least 24 weeks.
Outcome measures
| Measure |
Fulvestrant With Enzalutamide
n=32 Participants
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
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|---|---|
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Clinical Benefit Rate of the Combination of Enzalutamide/ Fulvestrant
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7 Participants
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SECONDARY outcome
Timeframe: 24 WeeksPopulation: all eligible patients
The safety of the combination of enzalutamide with fulvestrant will be assessed according to CTCAE 4.03.
Outcome measures
| Measure |
Fulvestrant With Enzalutamide
n=32 Participants
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
fatigue
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17 participants
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Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
nausea
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16 participants
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Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
vomiting
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9 participants
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Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
constipation
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10 participants
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Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
headache
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11 participants
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Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
diarrhea
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7 participants
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Number of Participants With Treatment-Emergent Adverse Events (Safety Profile)
cognitive dysfunction
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5 participants
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SECONDARY outcome
Timeframe: Up to 24 WeeksPopulation: all eligible patients
PFS is defined as the time from the first day of enzalutamide treatment (Study Day 1) until documented disease progression or death on study, whichever occurs first. Percent (%) progression free at 24 weeks is the number of patients without disease progression after 24 weeks follow-up.
Outcome measures
| Measure |
Fulvestrant With Enzalutamide
n=32 Participants
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
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|---|---|
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Percent Progression Free at 24 Weeks
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7 Participants
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Adverse Events
Fulvestrant With Enzalutamide
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fulvestrant With Enzalutamide
n=32 participants at risk
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
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Cardiac disorders
myocardial infarction
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3.1%
1/32 • Number of events 1 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Hepatobiliary disorders
cholecystitis
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3.1%
1/32 • Number of events 1 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Other adverse events
| Measure |
Fulvestrant With Enzalutamide
n=32 participants at risk
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given, in conjunction with Fulvestrant, PO daily.
Fulvestrant with Enzalutamide: 500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
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|---|---|
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General disorders
Fatigue
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53.1%
17/32 • Number of events 17 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Endocrine disorders
Hot Flashes
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18.8%
6/32 • Number of events 6 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Nervous system disorders
insomnia
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18.8%
6/32 • Number of events 6 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Gastrointestinal disorders
nausea
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50.0%
16/32 • Number of events 16 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Gastrointestinal disorders
vomiting
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28.1%
9/32 • Number of events 9 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Gastrointestinal disorders
constipation
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31.2%
10/32 • Number of events 10 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Gastrointestinal disorders
anorexia
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28.1%
9/32 • Number of events 9 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Nervous system disorders
headache
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34.4%
11/32 • Number of events 11 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Musculoskeletal and connective tissue disorders
achiness
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43.8%
14/32 • Number of events 14 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Nervous system disorders
cognitive dysfunction
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15.6%
5/32 • Number of events 5 • AEs collected during treatment (which lasted up to a year)
CTCAE 4.0 Collected with each monthly visit, patients kept diary.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place