eligibility_summary
Eligibility: Women 18–70, newly diagnosed high‑risk stage II–III breast cancer (incl. TNBC, HER2+, HR+/HER2− with high‑risk), ECOG 0–1, adequate blood counts and chemistries, LVEF≥55%, negative pregnancy test/contraception, consent. Exclude: stage IV, inflammatory or bilateral disease, prior anticancer therapy, recent major surgery, neuropathy≥2, major cardiac disease, drug allergy/steroid‑ineligible, active infection, immunodeficiency/HIV/transplant, other trials <28d, pregnant/lactating, recent hormone therapy, serious comorbidity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm, 3-cohort neoadjuvant trial in high-risk early/locally advanced breast cancer. Interventions: Utidelone (epothilone-class, non-taxane microtubule-stabilizing cytotoxic, binds β-tubulin to stabilize microtubules and arrest mitosis) combined as follows: (1) TNBC: utidelone + carboplatin (platinum DNA crosslinker causing DNA damage/apoptosis), (2) HR+/HER2−: utidelone + epirubicin (anthracycline, topoisomerase II inhibitor, DNA intercalation, ROS), (3) HER2+: utidelone + carboplatin + trastuzumab (anti-HER2 mAb blocking ERBB2 signaling, mediating ADCC) + pertuzumab (anti-HER2 mAb blocking HER2 dimerization, especially with HER3, ADCC). Targets/pathways: microtubules/mitotic spindle, DNA crosslinking and topo II, HER2/ERBB2 signaling and dimerization (PI3K/AKT/MAPK), immune effector ADCC. Cohorts target TNBC cells, HR+ HER2− cells, and HER2-overexpressing cells.