RecruitingPhase 2NCT05305924

Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

Phase II Trial Of Fulvestrant Plus Abemaciclib In Er-Positive, Her2-Negative Metastatic Breast Cancer Immediately After Failure Of A Cdk4/6 Inhibitor


Sponsor

The Methodist Hospital Research Institute

Enrollment

28 participants

Start Date

Feb 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether giving fulvestrant (a hormone-blocking drug) as a lead-in treatment before adding abemaciclib (a CDK4/6 inhibitor) can improve outcomes in postmenopausal women with estrogen receptor-positive (ER+), HER2-negative metastatic breast cancer that has already progressed on another CDK4/6 inhibitor plus aromatase inhibitor. **You may be eligible if...** - You are over 18 with confirmed ER+, HER2-negative metastatic breast cancer - Your cancer progressed while on a CDK4/6 inhibitor combined with an aromatase inhibitor as your most recent treatment - You have measurable disease on scans **You may NOT be eligible if...** - You have not previously been treated with a CDK4/6 inhibitor - Your cancer is HER2-positive - You have significant other health issues preventing participation 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

DRUGFulvestrant Run-In

The study is evaluating if a drug holiday (post CDK inhibitors progression) will reset the cell cycle machinery to be responsive to Abemaciclib and Fulvestrant.


Locations(1)

Houston Methodist Cancer Center

Houston, Texas, United States

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NCT05305924


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