OncoMatch/Clinical Trials/NCT05891093
Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)
Is NCT05891093 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for breast cancer.
Treatment: Fluzoparib · Anastrozole · Letrozole · Exemestane · Tamoxifen · Toremifene · Abemaciclib · LHRH agonist — This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (IHC ER ≥ 1%)
ER positive is defined as immunohistochemistry(IHC) detection of ER ≥ 1%
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+ with negative ISH)
HER2-negative is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver in situ hybridization (SISH)) test is required
Disease stage
Required: Stage T2-4N0-3M0
Excluded: Stage STAGE 4
Postoperative pathological stage T2-4N0-3M0; Has metastatic (Stage 4) breast cancer [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — neoadjuvant and/or adjuvant
Patients who have previously received neoadjuvant chemotherapy and/or adjuvant chemotherapy
Lab requirements
Blood counts
hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 10^9 /L; platelet count ≥ 100 * 10^9 /L
Kidney function
serum creatinine ≤ 1×ULN, endogenous creatinine clearance rate >50 ml/min (Cockcroft-Gault formula)
Liver function
ALT ≤ 3×ULN, AST ≤ 3×ULN, TBIL ≤ 1.5×ULN
Cardiac function
left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound) [excluded]
adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 10^9 /L; platelet count ≥ 100 * 10^9 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula); left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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