eligibility_summary
Adults 18–75 with unresectable LA/M HER2+ breast cancer, ≥1 RECIST 1.1 measurable lesion, ECOG 0–1, LVEF ≥50%, LE ≥3 mo, prior AEs ≤G1, adequate function, recent tumor tissue, neg pregnancy/contraception, no recent anticancer therapy. Exclusions: prior HER2‑ADC or topo I‑ADC, CNS mets, serious lung (ILD) or major cardiac/QT/arrhythmia/cerebrovascular disease, uncontrolled HTN, severe allergy (incl T‑DM1), immunosuppression/live vaccines/transplant, serious infection/bleeding, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Randomized Phase III trial in unresectable/metastatic HER2‑positive breast cancer compares BL‑M07D1 vs T‑DM1. BL‑M07D1: investigational HER2‑directed antibody‑drug conjugate (ADC), IV q3w, mechanism—antibody binds HER2 on tumor cells, is internalized, and releases a cytotoxic payload to induce cell death, retains HER2 signaling blockade and Fc‑mediated ADCC. T‑DM1 (ado‑trastuzumab emtansine): approved HER2‑directed ADC that, after HER2 binding/internalization, releases the microtubule inhibitor DM1, also preserves trastuzumab’s HER2 blockade and ADCC. Target cells/pathways: HER2‑overexpressing breast cancer cells, ERBB2/HER2 signaling axis, intracellular microtubules (with T‑DM1). Payload class for BL‑M07D1 is not specified in the registry.