The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
Voluntarily participate and sign the informed consent form;
Ages≥18 years;
Invasive breast tumour tissue with low HER2 expression confirmed by the central laboratory, defined as HER2 protein expression of IHC 1+ or IHC 2+ with no amplification by in situ hybridisation (ISH) (according to the Breast Cancer HER2 Detection Guidelines, 2019 edition) by immunohistochemistry; and specimens from the primary site of the tumour for HER2 detection (wax blocks, biopsies, or fresh tissues are acceptable) are available for HER2 detection
Tumour hormone receptor (HR)-negative, defined as IHC-stained invasive carcinoma with a proportion of cells positive for both ER and PgR nuclear staining of <1% according to ASCO/CAP guideline 2020;
With bilateral invasive breast cancer
Previous history of invasive breast cancer
Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery
Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration
Parallel
Disitamab Vedotin Injection （18 weeks）
Drug2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.
Toripalimab （18weeks）
Drug3.0 mg/kg, intravenous infusion, D1, every 2 weeks
Carboplatin
DrugAUC 3 Q2W or AUC1.5 QW intravenous infusion
Disitamab Vedotin Injection （12 weeks）
Drug2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.
Sequential Epirubicin
DrugAccording to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.
Sequential CTX
DrugAccording to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.
Toripalimab （12weeks）
Drug3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed.
Total pathological complete response (tpCR) rate (ypT0/Tis ypN0)
Defined as the proportion of participants with a pathological assessment of pCR (ypTO/Tis, ypNO) in the analyzed population;
Breast pathological complete response（bpCR）
Defined as the proportion of participants with a pathological assessment of bpCR in the analyzed population
Objective remission rate (ORR)
Objective response rate.ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Disease free survival（DFS）
From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause including 3- and 5-year event-free survival
Event free survival (EFS)
The time from random assignment to disease progression, including local progression before surgery; disease recurrence-local, regional, distant, ipsilateral noninvasive, or contralateral (invasive or noninvasive)-or death from any cause;
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