eligibility_summary
Adults (≥18), nonpregnant and using contraception if applicable, with invasive breast cancer (AJCC 8th) that progressed after anti‑HER2 therapy (TKIs for de novo stage IV or within 1 year of adjuvant HP). Require ≥1 RECIST 1.1 measurable lesion, ECOG 0–1, adequate organ function, no ECG ischemia, NYHA I, LVEF ≥55%, normal cTnI/BNP. Exclude: male/inflammatory BC, other recent cancers, other therapies/trials, major surgery <4 wks, prior ADCs, drug allergy, GI malabsorption, uncontrolled cardiac disease, cognitive impairment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Trastuzumab emtansine (T-DM1, ado-trastuzumab emtansine), an antibody-drug conjugate. Mechanism: the trastuzumab (humanized anti-HER2 IgG1) component binds HER2/ERBB2 on HER2-positive breast cancer cells, inhibits HER2-driven signaling (PI3K/AKT and MAPK), promotes receptor internalization, and induces Fcγ-mediated ADCC, the DM1 payload (maytansinoid microtubule inhibitor) is internalized and released to disrupt microtubules, causing mitotic arrest and apoptosis. Targets: HER2-overexpressing tumor cells, HER2/ERBB2 receptor and downstream survival/proliferation pathways, microtubule cytoskeleton, engages innate immune effector cells (NK cells/macrophages) via ADCC. Population: advanced HER2+ disease after TKIs or trastuzumab+pertuzumab.