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

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Cyclophosphamide; Epirubicin; Paclitaxel

Criteria

Inclusion Criteria:

1. Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer

2. Histopathologically confirmed early or locally advanced three-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:

HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1%

3. Tumor stage: II-III: Primary tumor size: ≥ 2cm

4. ECOG score 0 ~ 1;

5. Centrally confirmed BRCA1 or BRCA2 germline mutation;

6. Eligible level of organ function

Exclusion Criteria:

1. Patients with metastatic breast cancer or bilateral breast cancer or inflammatory breast cancer;

2. Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization;

3. Previously received PARPi therapy;

4. History of another primary malignancy;

5. Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia;

6. Female patients who are pregnant or lactating;

7. History of allergy to drugs in this study；