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
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.
• Sign the Informed Consent Form (ICF)
• The patient is judged by the investigator to have the ability to comply with the provisions of the protocol
• Women aged 18\
‣ 70 at the time of signing the ICF
• Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1
• Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0
• Histological results recorded as TNBC (negative HER2, ER and PgR status)
• Adequate excision: Patients must have undergone breast-conserving or mastectomy/nipple-sparing mastectomy.
• Pathological tumor-lymph node metastasis staging (IUCC/Joint American Committee on Cancer \[UICC/AJCC\], 8th edition): Patients undergoing pathologic lymph node status assessment must undergo sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection. As mentioned above, patients with simultaneous bilateral invasive disease are eligible only if all bilateral invasive lesions are confirmed by histological examination by the central laboratory as triple-negative lesions and bilateral pathopathological-lymph node metastasis staging has been completed. The interval between final breast cancer surgery (or the last surgery for cure if additional resection of breast cancer is required) and randomization should not exceed 8 weeks (56 days).
• 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: absolute neutrophil count (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; AST, ALT, and alkaline phosphatase≤ 2.5 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; Patients with known Gilbert disease and serum bilirubin levels ≤ 3× ULN may be admitted; For patients not receiving anticoagulant therapy: INR or aPTT ≤ 1.5 × ULN within 28 days prior to initiation of study therapy; For patients receiving anticoagulant therapy: a stable anticoagulant regimen within 28 days before the start of study therapy and a stable INR; creatinine clearance≥ 30 mL/min (calculated using the Cockcroft-Gault formula); Serum albumin ≥ 2.5 g/dL
⁃ For women of childbearing age: agree to remain abstinent (avoid heterosexual intercourse) or take an annual failure rate for at least 5 months during treatment and at least 5 months after the last dose of SHR1210 (carrelizumab), or 6 months after the last dose of paclitaxel or doxorubicin, or 12 months after the last dose of cyclophosphamide, whichever occurs last \< 1% of contraception. A woman who is postmenopausal but has not yet reached postmenopausal status (menopause lasts ≥for 12 consecutive months, for no reason other than menopause) and has not undergone sterilization (ovarian and/or hysterectomy) is considered fertile.
⁃ Have the willingness and ability to follow scheduled visits, treatment protocols, laboratory tests and other research procedures