OncoMatch/Clinical Trials/NCT05862064
A Multi-center, Randomized, Open-label, Phase III Study Comparing PD-1 Inhibitor Combined With Antivascular Therapy and Anthracycline/Taxane-based Adjuvant Chemotherapy Versus Anthracycline/Taxane-based Adjuvant Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer
Is NCT05862064 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including epirubicin,cyclophosphamide,paclitaxel,Carrelizumab and epirubicin,cyclophosphamide,paclitaxel for tnbc - triple-negative breast cancer.
Treatment: epirubicin,cyclophosphamide,paclitaxel,Carrelizumab · epirubicin,cyclophosphamide,paclitaxel — This review will evaluate the efficacy and safety of SHR1210 (Camrelizumab) and antivascular drug(Famitinib) in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential paclitaxel, or EC-P) in patients with early-stage high-risk TNBC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
negative HER2
Required: ESR1 negative
negative ER
Required: PR (PGR) negative
negative PgR status
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB, IIIC (UICC/AJCC 8th edition)
stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: except for treatments planned under this study condition
prior systemic anticancer therapy (eg, neoadjuvant therapy or adjuvant therapy) includes, but is not limited to, chemotherapy, anti-HER2 therapy (eg, trastuzumab emtansine, pertuzumab, lapatinib, neratinib or other tyrosine kinase inhibitors), hormone therapy, or anti-cancer RT, except for treatments planned under this study condition
Cannot have received: anthracycline
Previous treatment with anthracyclines or taxane for any malignant tumor
Cannot have received: taxane
Previous treatment with anthracyclines or taxane for any malignant tumor
Lab requirements
Blood counts
ANC ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Lymphocyte count ≥ 500 cells/μL; Platelet count ≥ 100,000 cells/μL (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL
Kidney function
creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
Liver function
AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN; serum total bilirubin ≤ 1.0 × ULN; Patients with known Gilbert disease and serum bilirubin levels ≤ 3× ULN may be admitted
Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: ... (see full text for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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