RecruitingPhase 2NCT05536128

Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

A Phase II Open Label, Umbrella Study Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors in Hormone Receptor-positive Advanced Breast Cancer After a CDK4/6 Inhibitor


Sponsor

Seoul National University Hospital

Enrollment

64 participants

Start Date

Dec 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Protocol Title: A Phase II open label, umbrella study evaluating the efficacy and safety of Fulvestrant plus DNA damage repair inhibitors in hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing combinations of fulvestrant (a hormone-blocking drug) with DNA damage repair inhibitors for women with hormone receptor-positive, HER2-negative breast cancer that has spread (metastatic) and progressed after prior hormone therapy and CDK4/6 inhibitor treatment. Researchers are exploring whether targeting DNA repair pathways can overcome treatment resistance. **You may be eligible if:** - You are 19 years or older - You have HR+/HER2-negative metastatic or inoperable breast cancer - Your cancer progressed after treatment with hormone therapy AND a CDK4/6 inhibitor (such as palbociclib, ribociclib, or abemaciclib) - You have adequate organ function (heart, liver, kidneys) - You are willing to provide tumor tissue for testing **You may NOT be eligible if:** - You have received more than a certain number of prior lines of therapy (per protocol limits) - You have active brain metastases - You have certain blood disorders or poor organ function - You are pregnant or breastfeeding 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

DRUGOlaparib

Olaparib tablet 300 mg taken orally twice daily Olaparib 500 mg on Days 1, 15, 29, and every 4 weeks thereafter The treatment will continue till disease progression or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met.

DRUGFulvestrant

Fulvestrant 500 mg on Days 1, 15, 29, and every 4 weeks thereafter


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT05536128


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