The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
Voluntarily participate and sign the informed consent form;
Ages≥18 years;
Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter > 2 cm), cN0- 3, M0;
Invasive breast tumour tissue confirmed HER2-positive by the central laboratory, defined as HER2 protein expression of IHC 3+ by immunohistochemistry (IHC) or IHC 2+ with amplification by in situ hybridisation (ISH) (according to the HER2 Guidelines for Breast Cancer, 2019 edition); and specimens from the primary site of the tumour for HER2 testing (wax blocks, sections or fresh tissue are acceptable) can be provided for HER2 testing;
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
Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs
Parallel
Disitamab Vedotin Injection
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.
Pertuzumab Injection
DrugInitial dose 840mg, after 2nd dose 420mg intravenous infusion， every 3 weeks
Toripalimab
Drug3.0 mg/kg, intravenous infusion, D1, every 2 weeks
Pathological complete response (pCR) rate (ypT0/is ypN0)
Pathological complete response rate after neoadjuvant ( both breast and axillary lymph nodes, in which the breast may have residual carcinoma in situ);
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;
Overall survival (OS)
OS is defined as the time from the date of randomisation until the date of death due to any cause.
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