NCT05065411Phase 3Terminated

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-10-19Actual

Enrollment · participants5Actual

Source updated2024-02-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Metastatic Breast Cancer

Treatments or interventions studied

Enobosarm & Abemaciclib ComboDrugAlso known as VERU-024, Verzenio
non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or FulvestrantDrugAlso known as exemestane, fulvestrant, exemestane plus everolimus

Primary outcomes · main study measures

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measure: Primary endpoint for the study is the median progression free survival (PFS) in the Enobosarm Combination Group compared to the Control Treatment Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 criteria; description: STAGE 1: To determine the safety of enobosarm 9 mg once daily (QD) used in combination with abemaciclib tablets, for oral use, 150 mg twice daily (BID)\]. STAGE 2: To demonstrate the efficacy of enobosarm in combination with abemaciclib (Enobosarm Combination Group) versus an estrogen blocking agent, (non-steroidal AI, steroidal AI (exemestane with or without everolimus) or fulvestrant Control Treatment Group) in the treatment of AR+ER+HER2 (AR% nuclei staining ≥40%) metastatic breast cancer as measured by PFS according to RECIST 1.1.; timeFrame: Day 1 to Day 300

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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