What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Selective Androgen Receptor Modulators (SARMs) like Enobosarm and CDK 4/6 inhibitors like Abemaciclib, have specific side effects. Abemaciclib is associated with diarrhea, fatigue, neutropenia, and an increased risk of venous thromboembolism (VTE), especially when combined with tamoxifen. SARMs like Enobosarm may cause side effects such as liver enzyme elevations and potential cardiovascular issues. Endocrine therapies, including aromatase inhibitors and tamoxifen, can lead to bone density loss, cardiovascular risks, and menopausal symptoms. Most adverse effects are manageable and reversible with appropriate interventions.

What prior FDA approvals exist?

The FDA has approved several CDK 4/6 inhibitors for the treatment of hormone receptor-positive (HR+), HER2-negative breast cancer, similar to Abemaciclib. These include Palbociclib (Ibrance), Ribociclib (Kisqali), and Abemaciclib (Verzenio). These drugs are often used in combination with hormone therapies like aromatase inhibitors or fulvestrant to improve progression-free survival in patients with advanced or metastatic breast cancer. While Selective Androgen Receptor Modulators (SARMs) like Enobosarm are still under investigation, they represent a novel approach targeting androgen receptors in breast cancer treatment.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Ribociclib and Palbociclib, which are other CDK 4/6 inhibitors; 2) Alpelisib, a PI3K inhibitor for patients with PIK3CA-mutated breast cancer; 3) Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2; 4) Pembrolizumab, an immune checkpoint inhibitor for PD-L1 positive tumors; and 5) Elacestrant, a novel oral selective estrogen receptor degrader (SERD). These alternatives offer different mechanisms of action and may be suitable based on specific patient profiles and tumor characteristics.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 300

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a combination of enobosarm and abemaciclib for patients with a specific type of breast cancer that has not responded to previous treatments. Enobosarm targets proteins in cancer cells to stop their growth, and abemaciclib prevents the cells from multiplying.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 300

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (partial response [PR] or complete response [CR]) on study

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective Androgen Receptor Modulators (SARMs) like Enobosarm work by selectively targeting androgen receptors in cancer cells, which can inhibit tumor growth and proliferation in certain types of breast cancer, particularly those that are androgen receptor-positive. Cyclin-Dependent Kinase 4/6 (CDK 4/6) inhibitors like Abemaciclib function by blocking the activity of enzymes CDK4 and CDK6, which are crucial for cell cycle progression. This inhibition prevents cancer cells from proliferating uncontrollably. These mechanisms are significant for breast cancer patients as they offer targeted treatment options that can be more effective and potentially have fewer side effects compared to traditional chemotherapy, especially for hormone receptor-positive subtypes of breast cancer.

nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer.Comparison of treatment-related adverse events of different Cyclin-dependent kinase 4/6 inhibitors in metastatic breast cancer: A network meta-analysis.