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 (Jun 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
Treatments studied
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT05862064 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIA or IIB or IIIA or IIIB or IIIC 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 qualify