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CDK 4/6 Inhibitor

Enobosarm + Abemaciclib for Breast Cancer (VERU-024 Trial)

Phase 3
Waitlist Available
Research Sponsored by Veru Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 300
Awards & highlights

VERU-024 Trial Summary

This trial is testing the safety of a new drug, enobosarm, when used with the existing drug Verzenio. The second part of the trial is testing whether the new drug combination is more effective than just Verzenio alone in treating metastatic breast cancer.

Who is the study for?
This trial is for adults with ER+HER2- metastatic breast cancer that worsened after certain treatments. Participants must be able to consent, communicate with researchers, and meet menopausal status criteria. Women of childbearing potential and men must agree to use contraception. They should have an ECOG performance status ≤2, measurable disease per RECIST 1.1, AR% nuclei staining ≥40%, and adequate organ function.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Enobosarm (9 mg daily) combined with Abemaciclib (150 mg twice daily) against standard Estrogen Blocking Agents in patients who've seen their cancer progress on previous estrogen blockers plus palbociclib. The goal is to compare progression-free survival times between the two groups.See study design
What are the potential side effects?
Potential side effects include reactions related to hormone therapies such as hot flashes or mood swings, digestive issues like nausea or diarrhea from oral medications, fatigue due to immune system impacts from chemotherapy agents, and possible increased risk of infections.

VERU-024 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are 18 years old or older.
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You have a moderate to high ability to perform daily activities.
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Your disease can be measured using a specific standard called RECIST 1.1.
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You have already been treated with certain medications and your condition got worse.
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Your organs are working well.

VERU-024 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 300
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 300 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary endpoint for the study is the median progression free survival (PFS) in the Enobosarm Combination Group compared to the Control Treatment Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 criteria
Secondary outcome measures
Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (partial response [PR] or complete response [CR]) on study

VERU-024 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enobosarm Combination GroupExperimental Treatment1 Intervention
Enobosarm Combination Group will receive enobosarm 9 mg each day by mouth (QD), and abemaciclib will administered by mouth at a dose of 150 mg BID. Stage 2 Subjects in the Enobosarm Combination Group will receive enobosarm 9 mg QD each day by mouth and abemaciclib 150 mg BID by mouth until disease progression is observed and confirmed by BICR.
Group II: Control Treatment GroupActive Control1 Intervention
Control Treatment Group will receive a non-steroidal AI, a non-steroidal or steroidal (exemestane with or without everolimus), AI OR fulvestrant approved for the treatment of metastatic breast cancer and is part of the standard of care at the clinical study site until disease progression is observed and confirmed by BICR. The decision of which comparator treatment will be used will be made prior to randomization.

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Who is running the clinical trial?

Veru Inc.Lead Sponsor
10 Previous Clinical Trials
687 Total Patients Enrolled
BarnetteStudy ChairVeru Inc.
9 Previous Clinical Trials
663 Total Patients Enrolled

Media Library

Abemaciclib (CDK 4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05065411 — Phase 3
Breast Cancer Research Study Groups: Enobosarm Combination Group, Control Treatment Group
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05065411 — Phase 3
Abemaciclib (CDK 4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05065411 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this continent-wide trial happening primarily in North America?

"Presently, this clinical trial is looking for patients from a total of 31 sites. While some of these sites are in cities like Saint Louis, Norfolk and Santa Barbara, others are located in more rural areas. If you enroll in the trial, it may be most convenient for you to choose a site that is nearby to avoid extensive travel."

Answered by AI

Is this research project only looking for volunteers above the age of 20?

"This clinical trial is for patients aged 18 to 100. There are 92 similar trials for patients that are younger and 2613 for patients that are older."

Answered by AI

For what purpose is the Enobosarm & Abemaciclib Combo most commonly used?

"Enobosarm & Abemaciclib Combo can be used to treat rejection, transplant, kidney, waldenstrom macroglobulinemia, and lung."

Answered by AI

Might I be able to enroll in this research program?

"This study is only looking for female patients that have been diagnosed with breast cancer. The age limit for this trial is 18 to 100 years old. Out of the 186 total patients needed, how many do you think the researchers will be able to find?"

Answered by AI

What are the risks associated with Enobosarm & Abemaciclib Combo?

"Enobosarm & Abemaciclib Combo is a Phase 3 trial medication, so it has received a score of 3 for safety. This reflects the presence of some data supporting efficacy as well as multiple rounds of data supporting safety."

Answered by AI

Are there other examples of Enobosarm & Abemaciclib being studied together?

"The first clinical trial for the Enobosarm & Abemaciclib Combo was at Rebecca and John Moores UCSD Cancer Center in 2003. 590 trials have completed since then. There are presently 343 actively recruiting studies, with many of these trials being performed out of Saint Louis, Missouri."

Answered by AI

Is this research open to new participants?

"Correct, the information available on clinicaltrials.gov affirms that this study is actively trying to enrol patients. The study was first posted on April 11th, 2022 and was last updated on October 14th, 2022. The study is looking for 186 patients at 31 sites."

Answered by AI
~2 spots leftby Mar 2025