eligibility_summary
Eligible: Plan ≥3 T-DM1 doses for HER2+ breast cancer, one prior dose allowed if ≤14 days and baseline survey within 14 days. Prior neurotoxic chemo and existing neuropathy allowed. Must continue follow-up at same site, give consent, and complete English questionnaires. Exclude: prior T-DM1 beyond one recent dose, concurrent neurotoxic chemo or neuropathy meds, prior use allowed if stopped ≥7 days.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Prospective observational study of the natural history of peripheral neuropathy in HER2-positive breast cancer patients receiving ado-trastuzumab emtansine (T-DM1) in adjuvant or metastatic settings. Drug/intervention: T-DM1, an antibody-drug conjugate (monoclonal antibody trastuzumab linked to the maytansinoid cytotoxin DM1). Mechanism: trastuzumab binds HER2/ERBB2 on tumor cells to inhibit HER2 signaling and mediate ADCC, after receptor-mediated internalization, DM1 is released to inhibit microtubules, causing mitotic arrest and cell death. Targets: HER2-overexpressing breast cancer cells, HER2 signaling pathways (e.g., PI3K/AKT/MAPK), microtubule/mitotic machinery, peripheral sensory neurons/axonal transport implicated in T-DM1–related neuropathy. Concomitant neurotoxic agents and neuropathy drugs are excluded.