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NCT05065411 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
A Phase 3 study, sponsored by Veru.
- Terminated
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT05065411: Clinical Trial Phase 3 study, sponsored by Veru.
NCT05065411 is a Phase 3 study that was terminated before completion, run by Veru. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05065411, a Phase 3 study, was terminated before completion, sponsored by Veru.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Enobosarm & Abemaciclib Combo
- DRUG non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-04-11 |
| Est. Completion | 2024-01-09 |
| Phase | Phase 3 |
Why NCT05065411 stopped before completion
NCT05065411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Enobosarm & Abemaciclib Combo is the first listed.
NCT05065411 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05065411 about?
NCT05065411 is a clinical study titled "Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer". 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 abemacicl...
What is the current status of trial NCT05065411?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2022-04-11. Estimated completion is 2024-01-09.
What interventions are being tested in trial NCT05065411?
The interventions under investigation include: Enobosarm & Abemaciclib Combo (DRUG), non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT05065411?
This trial is sponsored by Veru, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05065411's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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