RecruitingPhase 2NCT05933395

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)


Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

135 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best treatment options for postmenopausal women with hormone receptor-positive (ER+) breast cancer that has spread, after their cancer stopped responding to a class of drugs called CDK4/6 inhibitors (such as palbociclib, ribociclib, or abemaciclib). It uses genetic information from tumor samples to guide which treatment is best. **You may be eligible if...** - You are a postmenopausal woman, 18 or older - You have ER+ (hormone receptor-positive) breast cancer that has spread or cannot be cured - You previously received a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for advanced disease - You have had no more than 3 additional lines of therapy since the CDK4/6 inhibitor, and no more than 1 prior chemotherapy line - A recent biopsy of your cancer is available or obtainable **You may NOT be eligible if...** - Your cancer does not express estrogen receptors (ER-) - You have not yet received a CDK4/6 inhibitor - You cannot provide a tissue sample for genetic testing - Your general health or organ function does not meet study requirements 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

Fulvestrant will be administered intramuscularly into the buttocks in combination with one of the other interventions as outlined above.

DRUGNeratinib

Neratinib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.

DRUGAlpelisib

Alpelisib will be administered orally in tablet form once daily with food in combination with fulvestrant administration as outlined above.

DRUGEverolimus

Everolimus will be administered orally in tablet form once daily in combination with fulvestrant administration as outlined above.

DRUGAbemaciclib

Abemaciclib will be administered orally in tablet form twice daily in combination with fulvestrant administration as outlined above.


Locations(1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

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NCT05933395


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