This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.
Patients will receive SHR-A1811, until completion or treatment discontinuation due to progression, toxicity, or withdrawal. The primary endpoint is tpCR (ypT0/is ypN0). Secondary endpoints include bpCR, RCB, EFS, and safety. The study will recruit 30 eligible patients from multiple centers in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Drug: SHR-A1811 4.8mg/kg
tpCR
It is defined as the absence of residual invasive carcinoma in the resected breast cancer specimens stained with hematoxylin and eosin, and no cancer metastasis in all ipsilateral lymph node samples, after completion of neoadjuvant therapy and surgery.
Time frame: immediately after surgery
Breast Pathological Complete Response
It is defined as the absence of residual invasive carcinoma in the primary breast lesion after neoadjuvant therapy, with the permission of residual ductal carcinoma in situ within the primary breast lesion.
Time frame: immediately after surgery
event free survival
Time frame: until the end of the study
residual cancer burden
Time frame: immediately after surgery
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