eligibility_summary
Eligible: women 18–75 with newly treated invasive HER2+ breast cancer (early T1c–3 N0–1 M0 or locally advanced T2–3 N2/3 M0), ECOG 0–1, planned curative surgery, adequate labs/organ function, LVEF≥55%, QTcF<470, contraception if needed, consent. Exclude: drug allergy, prior anticancer/RT, major surgery <4 wks, stage IV, absorption issues, serious heart disease, psych illness/substance abuse, pregnancy/lactation, severe organ/blood disease, or investigator‑deemed unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, multi-cohort trial in HER2+ early breast cancer. Neoadjuvant regimen: pyrotinib (oral, irreversible pan‑ErbB small‑molecule TKI inhibiting EGFR/HER2/HER4) + trastuzumab (IV anti‑HER2 monoclonal antibody) + albumin‑bound paclitaxel (taxane microtubule stabilizer) + carboplatin (DNA‑crosslinking platinum). After surgery, adjuvant therapy is response‑adapted: pCR → pyrotinib, RCB‑1 → T‑DM1 (trastuzumab‑emtansine, anti‑HER2 ADC delivering DM1, a microtubule inhibitor), RCB≥2 → T‑DM1 + pertuzumab (anti‑HER2 mAb blocking HER2 dimerization). Targets: HER2‑overexpressing tumor cells and ErbB signaling (EGFR/HER2/HER4, HER2–HER3 dimerization), downstream PI3K/AKT/MAPK, microtubules (taxane/DM1), and DNA integrity (carboplatin). Trastuzumab/pertuzumab may also mediate ADCC.