eligibility_summary
Adults ≥18, ECOG 0–2, HER2+ non‑metastatic invasive breast cancer (cT1N1‑2 or cT2‑3N0‑2), candidates for neoadjuvant taxane/carboplatin/trastuzumab/pertuzumab/T‑DM1, no distant mets, adequate organ function, LVEF ≥50%, pretreatment tissue available, agree to surgery and contraception. Exclude: stage IV, drug hypersensitivity, bilateral invasive disease, prior systemic therapy/axillary surgery, inflammatory/ulcerating tumors, disqualifying prior cancers, major cardiac disease, recent major surgery/infection, pregnancy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, randomized trial in stage II–IIIA HER2+ early breast cancer comparing HER2DX-guided therapy vs physician-choice care. Intervention: HER2DX (molecular diagnostic device) stratifies risk/pCR likelihood to tailor neoadjuvant/adjuvant use of: trastuzumab (anti-HER2 monoclonal antibody, blocks HER2 signaling and mediates ADCC), pertuzumab (anti-HER2 monoclonal antibody, inhibits HER2 dimerization, especially with HER3), ado-trastuzumab emtansine/T-DM1 (HER2-targeted antibody-drug conjugate delivering the microtubule inhibitor DM1), paclitaxel or docetaxel (taxane microtubule stabilizers), and carboplatin (platinum DNA crosslinker). Targets: HER2-overexpressing tumor cells, HER2/ErbB2 signaling and HER2-HER3 dimerization, tumor cell microtubules/mitosis, DNA integrity/repair pathways, and immune effector ADCC mechanisms.