Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT05065411. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
P3 Efficacy Evaluation of Enobosarm in Combo With Abemaciclib Compared to Estrogen Blocking Agent for 2nd Line Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent Plus Palbociclib
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05065411
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Interventions
- Enobosarm & Abemaciclib Combo Drug
- non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 11, 2022 (Actual)
- Primary completion
- Oct 19, 2023 (Actual)
- Completion
- Jan 9, 2024 (Actual)
- Last update posted
- Feb 26, 2024
2022 – 2024
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | — |
| Banner MDACC | Gilbert | Arizona | 85234 | — |
| Arizona Oncology Associates, PC-HOPE | Tucson | Arizona | 85711 | — |
| Los Angeles Cancer Network One Oncology | Los Angeles | California | 90017 | — |
| UCLA Parkside Cancer Center | Los Angeles | California | 90095 | — |
| Sharp Center for Research | San Diego | California | 92123 | — |
| Sansum Clinic, CA | Santa Barbara | California | 93105 | — |
| Innovative Clinical Research Institute | Whittier | California | 90603 | — |
| Med OncologyHematology Consultants, PA Newark | Newark | Delaware | 19713-7007 | — |
| Lakes Research | Miami Lakes | Florida | 33014 | — |
| Maryland Oncology Hematology, P.A. | Annapolis | Maryland | 21401 | — |
| Baystate Regional Cancer Program - D'Amour Center for Cancer Care | Springfield | Massachusetts | 01199-1005 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39213 | — |
| Washington University St. Louis | St Louis | Missouri | 63110 | — |
| Renown Health | Reno | Nevada | 89502 | — |
| Summit Medical Group, Florham Park Campus | Florham Park | New Jersey | 07932-1049 | — |
| The New York Hospital | Westbury | New York | 11590 | — |
| The Lindner Center for Research and Education at the Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Toledo Clinic Cancer Centers - Main Office | Toledo | Ohio | 43623 | — |
| UPMC Magee-Women's Hospital | Pittsburgh | Pennsylvania | 15219 | — |
| Texas Oncology, PA | Dallas | Texas | 75246 | — |
| Texas Oncology, PA | Denton | Texas | 76201 | — |
| Texas Oncology, P.A. | El Paso | Texas | 79902 | — |
| Texas Oncology, P.A. | Flower Mound | Texas | 75028 | — |
| UT MD Anderson CC | Houston | Texas | 77030 | — |
| Texas Oncology, P.A. | San Antonio | Texas | 78240 | — |
| Texas Oncology, P.A. | Tyler | Texas | 75702 | — |
| Virginia Oncology Assoc | Norfolk | Virginia | 23502 | — |
| University of Washington Seattle Cancer Center Alliance (SCCA) | Seattle | Washington | 98109-1023 | — |
| Cancer Care Northwest | Spokane | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05065411, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 26, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05065411 live on ClinicalTrials.gov.