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 (Jun 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
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05891093 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemotherapy.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage T2-4N0-3M0 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages