Terminated PHASE3 INTERVENTIONAL 2-arm NCT05065411

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (VERU-024)

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

Sponsor: Veru Inc.

Conditions Metastatic Breast Cancer

Interventions Enobosarm & Abemaciclib Combo non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant

Updated 19 times since 2021 Last updated: Feb 23, 2024 Started: Apr 11, 2022 Primary completion: Oct 19, 2023 Completion: Jan 9, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Business decision

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A PHASE3 clinical study on Metastatic Breast Cancer, this trial is terminated or withdrawn. The trial is conducted by Veru Inc. and has accumulated 19 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

19 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Mar 2024 — Jul 2024 [monthly]

Terminated PHASE3

Status: Suspended → Terminated
Feb 2024 — Mar 2024 [monthly]

Suspended PHASE3

Status: Active Not Recruiting → Suspended

▶ Show 14 earlier versions

Oct 2023 — Feb 2024 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Apr 2023 — Oct 2023 [monthly]

Recruiting PHASE3
Mar 2023 — Apr 2023 [monthly]

Recruiting PHASE3
Feb 2023 — Mar 2023 [monthly]

Recruiting PHASE3
Jan 2023 — Feb 2023 [monthly]

Recruiting PHASE3
Nov 2022 — Jan 2023 [monthly]

Recruiting PHASE3
Oct 2022 — Nov 2022 [monthly]

Recruiting PHASE3
Sep 2022 — Oct 2022 [monthly]

Recruiting PHASE3
Jun 2022 — Sep 2022 [monthly]

Recruiting PHASE3
May 2022 — Jun 2022 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Apr 2022 — May 2022 [monthly]

Not Yet Recruiting PHASE3
Mar 2022 — Apr 2022 [monthly]

Not Yet Recruiting PHASE3

Phase: PHASE2 → PHASE3
Feb 2022 — Mar 2022 [monthly]

Not Yet Recruiting PHASE2
Nov 2021 — Feb 2022 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Veru Inc.

Data source: Veru Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Annapolis, United States , Chandler, United States , Cincinnati, United States , Dallas, United States , Denton, United States , El Paso, United States , Florham Park, United States , Flower Mound, United States , Gilbert, United States , Houston, United States and 19 more locations