eligibility_summary
Adults 18–70 with untreated T2–T3, any N, M0 HR+ HER2‑low invasive breast cancer, Ki‑67 >14%, ECOG 0–1, adequate organ/marrow, contraception x7 months (if childbearing) and consent. Exclude: metastatic/inflammatory BC, prior anti‑cancer therapy/radiation, concurrent anti‑tumor therapy, recent major surgery or not recovered, significant lung/heart disease, GI absorption issues, drug allergy, immunodeficiency/HIV/transplant, pregnant/lactating, serious comorbidities or investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SHR-A1811 (for injection) — an investigational HER2‑targeted antibody‑drug conjugate (ADC). Mechanism of action: the monoclonal antibody binds HER2 on tumor cells (including low‑HER2 expressers), is internalized, and releases a cytotoxic payload inside the cell, causing tumor cell death and suppressing proliferation. Targets (cells/pathways): HER2 (ERBB2) on HR‑positive breast cancer cells with low HER2 expression, downstream HER2/ERBB signaling pathways, leading to cell‑cycle arrest and apoptosis. Neoadjuvant use for 8 cycles before surgery.