OncoMatch/Clinical Trials/NCT05834582
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
Is NCT05834582 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Fluzoparib+Paclitaxel and Epirubicin+Cyclophosphamide for tnbc - triple-negative breast cancer.
Treatment: Fluzoparib+Paclitaxel · Epirubicin+Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: BRCA1 germline mutation
Centrally confirmed BRCA1 or BRCA2 germline mutation
Required: BRCA2 germline mutation
Centrally confirmed BRCA1 or BRCA2 germline mutation
Required: HER2 (ERBB2) negative (IHC 0/1+ or IHC2+ but ISH negative) (IHC 0/1+ or IHC2+ but ISH negative)
HER2 negative: IHC 0/1 + or IHC2 + but ISH negative
Required: ESR1 negative (IHC nuclear staining ≤ 1%) (IHC nuclear staining ≤ 1%)
ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1%
Required: PR (PGR) negative (IHC nuclear staining ≤ 1%) (IHC nuclear staining ≤ 1%)
ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1%
Disease stage
Required: Stage II, III
Excluded: Stage IV
Tumor stage: II-III: Primary tumor size: ≥ 2cm
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PARP inhibitor
Previously received PARPi therapy
Cannot have received: endocrine therapy
received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization
Cannot have received: immunotherapy
received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization
Cannot have received: biological therapy
received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization
Cannot have received: tumor embolization
received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization
Lab requirements
Cardiac function
Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia [excluded]
Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia [excluded]; Eligible level of organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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