RecruitingPhase 1Phase 2NCT05608252

VS-6766+Abema+Fulv in Met HR+/HER- BC

A Single Arm Phase 1/2 Trial of Abemaciclib + Avutometinib (VS-6766) + Fulvestrant in Metastatic HR+/HER2- Breast Cancer


Sponsor

Adrienne G. Waks

Enrollment

63 participants

Start Date

Feb 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer. The names of the study drugs involved in this study are: * VS-6766 * Abemaciclib * Fulvestrant


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — VS-6766 (a targeted therapy), abemaciclib (a CDK4/6 inhibitor), and fulvestrant (a hormone blocker) — for people with hormone receptor-positive, HER2-negative metastatic or locally advanced breast cancer that has spread or cannot be removed surgically. **You may be eligible if...** - You have confirmed hormone receptor-positive (HR+), HER2-negative metastatic or locally advanced unresectable breast cancer - You are male, premenopausal, or postmenopausal - You have measurable or non-measurable disease - You meet other health and organ function criteria set by the protocol **You may NOT be eligible if...** - Your tumor is HER2-positive or hormone receptor-negative - You have uncontrolled brain metastases or poor organ function - You are pregnant or breastfeeding (check full eligibility criteria with your doctor) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVS-6766

Taken Orally

DRUGAbemaciclib

Taken Orally

DRUGFulvestrant

Administered by intramuscular injection


Locations(3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institite

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05608252


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