NCT05911958 A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Patients aged 18 to 70 years old (inclusive); 2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0; 3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology; 4. ECOG performance status of 0-1; 5. Normal organ and bone marrow function; 6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding; 7. Patients voluntarily joined the study and signed informed consent; Exclusion Criteria: 1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer; 2. 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; 3. Patients received any other anti-tumor therapy at the same time

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