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Study identifier: NCT05065411 Synced from ClinicalTrials.gov · July 28, 2026
● Terminated

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

Condition: Metastatic Breast Cancer  ·  Sponsor: Veru Inc.

PhasePhase 3
Planned participants5
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNo

About this study

STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor \[Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)\]. STAGE 2: To demonstrate the efficacy and safety of enobosarm 9 mg QD in combination with abemaciclib 150 mg BID (Enobosarm Combination Group) versus Estrogen Blocking Agent (Control Treatment Group) in the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), androgen receptor positive (AR+) with a AR% nuclei staining ≥40% metastatic breast cancer that have previously experienced disease progression on an estrogen blocking agent plus (palbociclib) as measured by progression free survival (PFS) according to RECIST 1.1 criteria.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (30)

Ironwood Cancer & Research CentersChandler, Arizona, United States
Banner MDACCGilbert, Arizona, United States
Arizona Oncology Associates, PC-HOPETucson, Arizona, United States
Los Angeles Cancer Network One OncologyLos Angeles, California, United States
UCLA Parkside Cancer CenterLos Angeles, California, United States
Sharp Center for ResearchSan Diego, California, United States
Sansum Clinic, CASanta Barbara, California, United States
Innovative Clinical Research InstituteWhittier, California, United States
Med OncologyHematology Consultants, PA NewarkNewark, Delaware, United States
Lakes ResearchMiami Lakes, Florida, United States
Maryland Oncology Hematology, P.A.Annapolis, Maryland, United States
Baystate Regional Cancer Program - D'Amour Center for Cancer CareSpringfield, Massachusetts, United States

+ 18 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05065411