Trial Outcomes & Findings for A Study of Lerociclib in Participants With Advanced Breast Cancer (NCT NCT05085002)
NCT ID: NCT05085002
Last Updated: 2026-05-14
Results Overview
The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
46
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
54
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Lerociclib in Participants With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
n=54 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
n=46 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
Mexico
|
5 participants
n=1512 Participants
|
9 participants
n=504 Participants
|
14 participants
n=2016 Participants
|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 11.91 • n=1512 Participants
|
57.7 years
STANDARD_DEVIATION 11.23 • n=504 Participants
|
58.7 years
STANDARD_DEVIATION 11.59 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=1512 Participants
|
46 Participants
n=504 Participants
|
99 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=1512 Participants
|
10 Participants
n=504 Participants
|
15 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=1512 Participants
|
35 Participants
n=504 Participants
|
83 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=1512 Participants
|
42 Participants
n=504 Participants
|
92 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
Belgium
|
11 participants
n=1512 Participants
|
2 participants
n=504 Participants
|
13 participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=1512 Participants
|
3 participants
n=504 Participants
|
19 participants
n=2016 Participants
|
|
Region of Enrollment
Moldova
|
11 participants
n=1512 Participants
|
4 participants
n=504 Participants
|
15 participants
n=2016 Participants
|
|
Region of Enrollment
Georgia
|
11 participants
n=1512 Participants
|
28 participants
n=504 Participants
|
39 participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.Population: 100 participants analyzed in total (N=54 1L, N=46 2L) however the quantity of data collected at the study termination was not sufficient to complete the final end-of study analysis per the protocol design.
The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.
Outcome measures
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
n=54 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
n=46 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
|---|---|---|
|
Incidence of AEs and SAEs
TEAEs Leading to Drug Interruption
|
10 participants
|
8 participants
|
|
Incidence of AEs and SAEs
TEAEs Leading to Dose Reduction
|
3 participants
|
1 participants
|
|
Incidence of AEs and SAEs
TEAEs Leading to Drug Discontinuation
|
9 participants
|
0 participants
|
|
Incidence of AEs and SAEs
TEAEs Leading to Any Dose Modification
|
3 participants
|
1 participants
|
|
Incidence of AEs and SAEs
TEAEs Leading to Study Discontinuation
|
3 participants
|
1 participants
|
|
Incidence of AEs and SAEs
AE Prior to Treatment Leading to Drug Interruption
|
1 participants
|
0 participants
|
|
Incidence of AEs and SAEs
Any AE Prior to Treatment
|
11 participants
|
12 participants
|
|
Incidence of AEs and SAEs
Serious TEAE
|
4 participants
|
2 participants
|
|
Incidence of AEs and SAEs
Serious AE Prior to Treatment
|
1 participants
|
1 participants
|
|
Incidence of AEs and SAEs
Serious, Related TEAEs
|
3 participants
|
1 participants
|
|
Incidence of AEs and SAEs
TEAEs Resulting in Death
|
1 participants
|
0 participants
|
|
Incidence of AEs and SAEs
Related TEAEs Resulting in Death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.Population: 115 participants screened to enroll 100 participants (n=54-1L n=46-2L). All participants discontinued from study primarily for study termination (83%). 1L pop of newly diagnosed, treatment-naive participants w/ HR+/HER2- mBC; 2L pop of participants w/ HR+/HER2- mBC who progressed on 1L endocrine tx such as tamoxifen, anastrozole, or letrozole; ORR defined as % participants achieving confirmed CR or confirmed PR (RECIST). CBR defined as % participants having achieved confirmed CR/confirmed PR/SD.
Objective response rate, defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator.
Outcome measures
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
n=39 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
n=35 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
|---|---|---|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Complete Response (CR) (confirmed)
|
0 participants
|
0 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Partial Response (PR) (confirmed)
|
9 participants
|
4 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Stable Disease (SD)
|
22 participants
|
20 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Progressive Disease (PD)
|
4 participants
|
8 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Not Evaluable (NE)
|
0 participants
|
0 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Non-Complete Response/ Non-Progressive Response
|
0 participants
|
0 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
No Evidence of Disease (NED)
|
0 participants
|
0 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Overall Response Rate (ORR)
|
9 participants
|
4 participants
|
|
To Characterize the Safety and Tolerability of Lerociclib in Combination With Endocrine Therapy in Participants With 1L and 2L Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor 2-negative (HER2-) Metastatic Breast Cancer (mBC).
Clinical Benefit Rate (CBR)
|
31 participants
|
24 participants
|
SECONDARY outcome
Timeframe: The timeframe for data collection was up to 18 months.Population: Kaplan-Meier Estimates for Progression-free Survival (Full Analysis Set). The evaluable efficacy data collected prior to the early termination of the study by the Sponsor are provided. 2L data at 12 and 18 months were not estimable due to insufficient data data (incomplete or missing).
A secondary endpoint for this study was to investigate the efficacy of lerociclib in combination with endocrine therapy in participants with 1L and 2L HR+/HER2- mBC by line of therapy. Probability of Progression-Free Survival (PFS) was measured. Per protocol, PFS was defined as the time from first dose of lerociclib until the date of documented progressive disease (PD) or death, according to RECIST v1.1 as assessed by the Investigator.
Outcome measures
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
n=54 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
n=46 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
|---|---|---|
|
Probability of Progression-Free Survival (PFS)
Probability of Progression-free Survival up to 6 months
|
0.82 probability
|
0.70 probability
|
|
Probability of Progression-Free Survival (PFS)
Probability of Progression-free Survival up to 12 months
|
0.82 probability
|
NA probability
For 12 months, the estimated PFS rates for 2L population were not estimable because there was an insufficient number of participants with events.
|
|
Probability of Progression-Free Survival (PFS)
Probability of Progression-free Survival up to 18 months
|
0.82 probability
|
—
|
SECONDARY outcome
Timeframe: Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.Population: The evaluable efficacy data collected prior to the early termination of the study by the Sponsor are provided. Kaplan-Meier Estimates for Progression-free Survival.
Progression-free survival (PFS), defined as the time from first dose of lerociclib until the date of documented progressive disease (PD) or death, according to RECIST v1.1 as assessed by the Investigator.
Outcome measures
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
n=54 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
n=46 Participants
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
|---|---|---|
|
Description of Kaplan-Meier Estimates Analysis for Progression-free Survival Event Analysis
Number of Participants with events prior to the date of the last valid RECIST assessment
|
4 number of participants
|
8 number of participants
|
|
Description of Kaplan-Meier Estimates Analysis for Progression-free Survival Event Analysis
Number of participants Censored as of the date of the last valid RECIST assessment
|
50 number of participants
|
38 number of participants
|
Adverse Events
Lerociclib + Letrozole or Fulvestrant 1L
Serious events: 4 serious events
Other events: 23 other events
Deaths: 5 deaths
Lerociclib + Letrozole or Fulvestrant 2L
Serious events: 2 serious events
Other events: 18 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
n=54 participants at risk
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
n=46 participants at risk
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.9%
1/54 • Number of events 2 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Psychiatric disorders
Psychosis
|
1.9%
1/54 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Reproductive system and breast disorders
Pneumonitis
|
1.9%
1/54 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Ear and labyrinth disorders
Vertgo
|
1.9%
1/54 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
General disorders
Pyrexia
|
1.9%
1/54 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
1.9%
1/54 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Infections and infestations
Bacterial Sepsis
|
1.9%
1/54 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/54 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/54 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/54 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
Other adverse events
| Measure |
Lerociclib + Letrozole or Fulvestrant 1L
n=54 participants at risk
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
Lerociclib + Letrozole or Fulvestrant 2L
n=46 participants at risk
Letrozole, administered orally once daily in tablet form at 2.5 mg.
Fulvestrant, administered as an intramuscular injection, once every 2 weeks for the initial 3 doses and then once every 4 weeks (Q4W) thereafter, at 500 mg.
Lerociclib + Letrozole or Fulvestrant: All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.
|
|---|---|---|
|
Investigations
Neutrophil Count Decrease
|
29.6%
16/54 • Number of events 41 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
34.8%
16/46 • Number of events 47 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Investigations
White Blood Cell Count Decrease
|
25.9%
14/54 • Number of events 32 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
23.9%
11/46 • Number of events 34 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Investigations
Alanine Aminotransferase Increased
|
9.3%
5/54 • Number of events 9 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
6.5%
3/46 • Number of events 4 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Investigations
Aspartate Aminotransferase Increase
|
7.4%
4/54 • Number of events 5 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
6.5%
3/46 • Number of events 3 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Investigations
Blood Creatinine Increase
|
7.4%
4/54 • Number of events 5 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Gastrointestinal disorders
Diarrhea
|
42.6%
23/54 • Number of events 32 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
26.1%
12/46 • Number of events 14 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Gastrointestinal disorders
Nausea
|
37.0%
20/54 • Number of events 23 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
19.6%
9/46 • Number of events 9 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Gastrointestinal disorders
Vomiting
|
13.0%
7/54 • Number of events 9 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
8.7%
4/46 • Number of events 6 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Blood and lymphatic system disorders
Anemia
|
25.9%
14/54 • Number of events 25 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
23.9%
11/46 • Number of events 16 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.2%
12/54 • Number of events 44 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
8.7%
4/46 • Number of events 9 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
6/54 • Number of events 17 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
General disorders
Fatigue
|
31.5%
17/54 • Number of events 22 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
17.4%
8/46 • Number of events 8 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
General disorders
Edema Peripheral
|
7.4%
4/54 • Number of events 4 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Infections and infestations
Urinary Tract Infection
|
13.0%
7/54 • Number of events 10 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
19.6%
9/46 • Number of events 12 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.3%
5/54 • Number of events 6 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
6.5%
3/46 • Number of events 4 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.0%
7/54 • Number of events 9 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
4.3%
2/46 • Number of events 2 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.0%
7/54 • Number of events 7 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
0.00%
0/46 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
3/54 • Number of events 3 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
4.3%
2/46 • Number of events 3 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
5/54 • Number of events 5 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
4.3%
2/46 • Number of events 2 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Nervous system disorders
Headache
|
11.1%
6/54 • Number of events 6 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
4.3%
2/46 • Number of events 2 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.3%
5/54 • Number of events 5 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Vascular disorders
Hot Flush
|
7.4%
4/54 • Number of events 4 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 2 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Psychiatric disorders
Insomnia
|
7.4%
4/54 • Number of events 4 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
4.3%
2/46 • Number of events 2 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
4/54 • Number of events 5 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
2.2%
1/46 • Number of events 1 • Data were collected from study baseline until close-out visit per patient which was approximately 30 days after the last dose. This study data collection time frame varied per patient due to study termination with an average of 237.4 days on treatment.
A total of 100 participants (n = 54 in the 1L population and n = 46 in the 2L population) comprised the Safety Analysis Set, based on their exposure to study intervention (non-investigational medicinal product or investigational medicinal product) prior to early termination of the study by the Sponsor. All adverse events and the reported TEAEs by Medical Dictionary for Regulatory Activities system organ class (SOC) and preferred term (≥5%) are presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place