The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
Voluntarily agree to participate in the study and sign the informed consent;
Age ≥18 years old (including the threshold value);
Histologically confirmed invasive breast cancer with clinical stage T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0;
As assessed by the research Center, the subjects can tolerate and plan to undergo radical surgery for breast cancer and have not previously received any anti-tumor systemic therapy for breast cancer;
Bilateral invasive breast cancer;
Previous history of invasive breast cancer;
Previously had carcinoma in situ of the breast and received adjuvant endocrine therapy within 5 years of surgery;
Use of the investigational drug or major surgery within 4 weeks prior to study dosing;
Single group
Disitamab Vedotin for Injection
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
Toripalimab
Drug3.0 mg/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 therapy 3.0 mg/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.
Epirubicin
DrugAccording to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed.
Cyclophosphamide
DrugAccording to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks , Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed
Total pathological complete response (tpCR) rate
Defined as the proportion of participants with a pathological assessment of pCR (ypT0/Tis, ypN0) 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
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
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
Objective Response Rate (ORR)
Objective response rate.ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
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