Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (ARTEST)
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|ClinicalTrials.gov Identifier: NCT04869943|
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : August 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Enobosarm Drug: Exemestane||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects in the Enobosarm Treatment Group will receive enobosarm 9mg each day by mouth until disease progression or an unacceptable adverse event is observed. Subjects in the Control Treatment Group will receive a ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus or selective estrogen receptor modulator(SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site. The decision of which comparator treatment will be used will be made prior to randomization.|
|Masking:||None (Open Label)|
|Official Title:||Randomized Crossover Ph3 to Evaluate Efficacy/Safety of Enobosarm Monotherapy vs Active Control for Treatment of AR+/ER+/HER2- MBC With AR Staining ≥40% Previously Treated w/Nonsteroidal Aromatase Inhibitor, SERD & CDK 4/6 Inhibitor|
|Actual Study Start Date :||October 12, 2021|
|Estimated Primary Completion Date :||March 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
Experimental: Enobosarm Treatment Group
Subjects in the Enobosarm Treatment Group will receive enobosarm 9mg each day by mouth until disease progression or an unacceptable adverse event is observed. The total duration of the study for a subject in the study from screening to follow-up visit is not standardized and will be different for each subject.
Oral Enobosarm 9mg per day
Other Name: VERU-024
Active Comparator: Control Treatment Group
Subjects in the Control Treatment Group will receive an ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus or selective estrogen receptor modulator (SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site. The decision of which comparator treatment will be used will be made prior to randomization. After radiographic progression, subjects randomized to the Control Treatment Group may be crossed over to receive enobosarm 9mg.
Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM)
Other Name: Mestane
- To demonstrate the efficacy of Enobosarm in the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS). [ Time Frame: Day 120 ]
The primary endpoint for the study is the median radiographic progression free survival (rPFS) in the Enobosarm Treatment Group compared to the Control Treatment Group.
Progression will be defined based on RECIST 1.1.
- Objective Response Rate (ORR) [ Time Frame: Day 180 ]Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (PR or CR) on study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869943
|Study Chair:||Barnette||Veru Inc.|