eligibility_summary
Eligible: women ≥18, treatment‑naive, histology‑confirmed HER2+ invasive breast cancer (IHC3+ or IHC2+/ISH+), stage T1c–2 N0–1 M0 with measurable disease, ECOG 0–1, adequate labs, LVEF ≥55%, negative pregnancy test/contraception, consent. Exclude: prior/ongoing therapy, bilateral/inflammatory/occult BC, other recent cancer, severe organ, cardiac, or GI absorption issues, immunodeficiency/viral hepatitis, allergy, recent trials, pregnancy/lactation, serious comorbid or neuro/psychiatric disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06483386 tests a neoadjuvant triple regimen in early HER2+ breast cancer: 1) Pyrotinib (oral small‑molecule, irreversible pan‑ErbB tyrosine kinase inhibitor targeting EGFR/HER1, HER2, HER4, blocks PI3K/AKT and MAPK signaling). 2) Trastuzumab SC (humanized anti‑HER2 monoclonal antibody, inhibits HER2 signaling/dimerization and triggers Fcγ‑mediated ADCC by NK cells). 3) Capecitabine (oral prodrug of 5‑fluorouracil, an antimetabolite that inhibits thymidylate synthase, impairing DNA synthesis). Premenopausal patients also receive goserelin (GnRH agonist causing ovarian suppression and reduced estrogen). Targets/pathways: HER2/ErbB receptors on tumor cells, EGFR family signaling, downstream PI3K/AKT/mTOR and RAS/RAF/MEK/ERK, immune ADCC via NK cells, tumor nucleotide/DNA synthesis, HPG axis (ovarian function).