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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 is a Phase 3 study that was terminated before completion, run by Veru. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05065411
The ClinicalTrials.gov registry entry for NCT05065411 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Veru, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enobosarm & Abemaciclib Combo is the first listed.
NCT05065411 reports 0 study locations.
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.
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