RecruitingPhase 2NCT05834582

Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer

Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

60 participants

Start Date

Apr 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a PARP inhibitor drug called fluzoparib (a type of targeted oral therapy) given before surgery can help shrink tumors in women with early to locally advanced triple-negative breast cancer who carry a BRCA1 or BRCA2 gene mutation. BRCA mutations make cancer cells more sensitive to this type of drug. **You may be eligible if...** - You are a woman between 18 and 70 years old with newly diagnosed triple-negative breast cancer (hormone receptor-negative, HER2-negative) - Your tumor is at least 2 cm and at stage II or III - You carry a confirmed BRCA1 or BRCA2 gene mutation - You have not yet received any cancer treatment - Your overall health and organ function meet required levels **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (metastatic) - You have bilateral or inflammatory breast cancer - You have previously received a PARP inhibitor drug - You have a history of heart failure or severe irregular heartbeat - 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+Paclitaxel

Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy

DRUGEpirubicin+Cyclophosphamide

Epirubicin+Cyclophosphamide


Locations(1)

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05834582


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