RecruitingPhase 2NCT05759546

PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

PARP Inhibitor in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer


Sponsor

Fudan University

Enrollment

200 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three medications — a PARP inhibitor, a CDK4/6 inhibitor, and hormone therapy — in women with advanced hormone receptor-positive, HER2-negative breast cancer that belongs to a specific molecular subtype (SNF-3). Combining these drugs targets multiple pathways the cancer uses to grow. **You may be eligible if...** - You are a female, 18–75 years old - You have advanced breast cancer that is hormone receptor-positive (ER/PR positive) and HER2-negative - Your cancer has been confirmed to be the SNF-3 molecular subtype - You are postmenopausal or can have ovarian suppression **You may NOT be eligible if...** - Your cancer is HER2-positive or hormone receptor-negative - You have previously received CDK4/6 inhibitor therapy - You have another active cancer or serious organ problems - 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

DRUGFluzoparib

Parp inhibitor

DRUGDalpiciclib

CDK4/6 inhibitor

DRUGFulvestrant/AI

Endocrine therapy


Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05759546


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