eligibility_summary
Eligible: HER2-positive unresectable locally advanced/metastatic breast cancer, prior taxane and trastuzumab, starting first-ever T-DM1. Ineligible: not receiving T-DM1 per standard-of-care/label, prior T-DM1 exposure, currently in any clinical trial, participated in an anti-HER2 trial within 1 year before T-DM1 start.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05945927 evaluates trastuzumab emtansine (T-DM1, ado-trastuzumab emtansine) in Chinese patients with HER2-positive advanced breast cancer in real-world practice (post-marketing, observational, second- or later-line after taxane+trastuzumab). Drug/intervention: T-DM1 is an antibody-drug conjugate (ADC) combining trastuzumab (humanized anti-HER2 IgG1) with DM1 (emtansine), a maytansinoid microtubule inhibitor. Mechanism: trastuzumab binds HER2 (ErbB2) on tumor cells, inhibits HER2 signaling and mediates ADCC, the complex is internalized and releases DM1 to bind tubulin, disrupt microtubules, arrest the cell cycle, and induce apoptosis. Targets: HER2-overexpressing breast cancer cells, HER2/ErbB2 signaling pathway, microtubules, engagement of immune effector cells via Fc for ADCC.