OncoMatch/Clinical Trials/NCT07162051
A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer
Is NCT07162051 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fuzaparib for hr+/her2- early breast cancer.
Treatment: Fuzaparib — The purpose of this clinical trial is to evaluate the efficacy and safety of Fluzoparib combined with docetaxel in sequential paclitaxel combined with cyclophosphamide for HRD-positive, HR+/HER2- early breast cancer. The main question it aims to answer is: Does the proportion of patients with residual tumor burden (RCB) 0/I increase when Fluzoparib combined with docetaxel is sequentially followed by paclitaxel combined with cyclophosphamide for patients with HRD-positive, HR+/HER2- early breast cancer? What medical problems will participants encounter when using Fluzoparib combined with docetaxel in sequential paclitaxel combined with cyclophosphamide? Participants will: After confirming their enrollment, they need to receive the trial drug treatment within 72 hours, with each 3-week period as a treatment cycle, for a total of 8 cycles. The first to fourth cycles will receive Fluzoparib combined with docetaxel treatment, and the fifth to eighth cycles will receive paclitaxel and cyclophosphamide treatment. The treatment will continue until the end of the treatment course or disease progression, occurrence of intolerable toxicity, or the subject withdrawing the informed consent form.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: BRCA1 pathogenic mutation
HRD-positive: defined as HRD score ≥42 points and/or germline BRCA1/2 mutation (pathogenic or likely pathogenic)
Required: BRCA2 pathogenic mutation
HRD-positive: defined as HRD score ≥42 points and/or germline BRCA1/2 mutation (pathogenic or likely pathogenic)
Required: ESR1 overexpression (IHC >1%) (IHC >1%)
ER-positive: IHC >1%
Required: PR (PGR) overexpression (IHC >1%) (IHC >1%)
PR-positive: IHC >1%
Required: HER2 (ERBB2) negative (IHC 0/1+ or IHC 2+ with negative ISH) (IHC 0/1+ or IHC 2+ with negative ISH)
HER2-negative: IHC 0/1+ or IHC 2+ with negative ISH
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PARP inhibitor
Previous treatment with PARP inhibitors
Cannot have received: endocrine therapy
Exception: within 4 weeks before enrollment
receipt of any anti-tumor therapy (including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy, or tumor embolization) within 4 weeks before enrollment
Cannot have received: bisphosphonate therapy
Exception: within 4 weeks before enrollment
receipt of any anti-tumor therapy (including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy, or tumor embolization) within 4 weeks before enrollment
Cannot have received: immunotherapy
Exception: within 4 weeks before enrollment
receipt of any anti-tumor therapy (including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy, or tumor embolization) within 4 weeks before enrollment
Cannot have received: biological therapy
Exception: within 4 weeks before enrollment
receipt of any anti-tumor therapy (including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy, or tumor embolization) within 4 weeks before enrollment
Cannot have received: tumor embolization
Exception: within 4 weeks before enrollment
receipt of any anti-tumor therapy (including endocrine therapy, bisphosphonate therapy, immunotherapy, biological therapy, or tumor embolization) within 4 weeks before enrollment
Lab requirements
Blood counts
ANC ≥1.5×10^9/L (no use of hematopoietic stimulating factors within 14 days before first administration); Platelet count ≥100×10^9/L (no blood transfusion within 14 days before first administration); Hemoglobin ≥90 g/L
Kidney function
Blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN
Liver function
Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN
Cardiac function
LVEF ≥50%; QTc interval <470 ms in females
Organ function must meet the following requirements: Hematology: ANC ≥1.5×10^9/L (no use of hematopoietic stimulating factors within 14 days before the first administration of the study drug); Platelet count (PLT) ≥100×10^9/L (no blood transfusion within 14 days before the first administration of the study drug); Hemoglobin (Hb) ≥90 g/L; Blood biochemistry: Total bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤2.5×ULN; BUN and creatinine ≤1.5×ULN; Cardiac function: LVEF ≥50%; QTc interval <470 ms in females
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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