HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
Patients aged 18 to 70 years old (inclusive);
Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
ECOG performance status of 0-1;
Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;
Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;
Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;
Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;
Single group
SHR-A1811 for injection
DrugSHR-A1811 for injection
Objective Response Rate (ORR) Tumours (RECIST) v1.1
Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid
Incidence of Adverse Events
Evaluate the nature, incidence and severity of SHR-A1811 adverse events according to CTCAE 5.0
Residual cancer burden (RCB)
Residual cancer burden (RCB)
Pathological complete response
pCR: ypT0/is ypN0
Event-free survival (EFS)
EFS was defined as the time from randomization to any of the following events: disease progression during neoadjuvant therapy, local or distant recurrence, second primary malignancy (breast or other cancer), or death from any cause
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