eligibility_summary
Eligibility: Adults 18–65, ECOG 0–1, clinical T2–T4d or T1c with axillary LN+, HER2+ invasive breast cancer (IHC 3+ or FISH+), measurable lesion on imaging within 1 mo, adequate marrow/organ function, LVEF ≥55%, negative pregnancy test, consent. Exclude: Stage IV, prior therapy, other active malignancy (except treated skin), recent major non-breast surgery, significant cardiac disease or uncontrolled HTN, serious comorbidity, drug allergy, immunodeficiency/HIV or transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05918328 tests two neoadjuvant regimens for HER2+ breast cancer. Experimental: nab-paclitaxel (albumin-bound taxane, microtubule stabilizer), trastuzumab (anti‑HER2 monoclonal antibody, inhibits HER2 signaling and mediates ADCC), and pyrrolitinib (oral small‑molecule HER2/ErbB tyrosine kinase inhibitor). Comparator (TCbHP): docetaxel (taxane, microtubule stabilizer), carboplatin (platinum DNA crosslinker), trastuzumab (anti‑HER2 mAb), and pertuzumab (anti‑HER2 mAb blocking HER2 dimerization, esp. HER2‑HER3). Targets/pathways: HER2-overexpressing tumor cells, ErbB/HER2 signaling (PI3K/AKT/MAPK), HER2 dimerization, mitotic spindle/microtubules, and DNA damage/repair, immune effector ADCC via trastuzumab/pertuzumab. The study evaluates non-inferiority and potential lower toxicity of the TKI-based regimen.