Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- Veru Inc.
- Study ID
- NCT04869943
- Phase
- PHASE3
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Enobosarm — DRUGOral Enobosarm 9mg per day
- Exemestane — DRUGExemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM)
Study Details
To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).
Key Dates
- Start date
- Oct 12, 2021
- Status verified
- Jan 2024
- Primary completion
- Jan 9, 2024
- Completion
- Jan 9, 2024
Study Design
- Enrollment
- 52 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Enobosarm Treatment GroupSubjects 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.
- Active Comparator: Control Treatment GroupSubjects 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.
Primary Outcome Measure
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 ]
Locations (34)
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Ironwood Cancer and Research Centers· Chandler, AZBanner Health/ Banner MD Anderson Cancer Center· Gilbert, AZThe Oncology Insitute of Hope and Innovation· Glendale, CAMarin Cancer Care, Inc.· Greenbrae, CACalifornia Research Institute (CRI)· Los Angeles, CAUniversity of California San Francisco Comprehensive Cancer Center· San Francisco, CA
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