eligibility_summary
Adults ≥18 with unresectable locally advanced or metastatic breast cancer, any HR/HER2, prior ADCs. If HR+, must have prior CDK4/6 (stopped ≥14 d, no ET washout). Requires measurable disease, adequate organs, LVEF≥50, ECOG≤2, life ≥3 mo. No recent (≤3 wk) RT/targeted/surgery, recovered AEs, neuropathy ≤G1. Exclude uncontrolled CNS mets, recent serious cardiac disease, uncontrolled effusions, recent steroids, active autoimmune/HBV/HCV/uncontrolled HIV, pregnancy, other malignancy ≤5 y, severe allergy, serious illness, or per PI.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II adaptive platform testing antibody–drug conjugate (ADC) rechallenge in metastatic breast cancer. Interventions/mechanisms: 1) SHR-A1811: HER2-directed ADC (monoclonal antibody to ERBB2 linked to a cytotoxic payload). Binds HER2 on tumor cells, is internalized, and releases payload to kill HER2-expressing cells (with potential bystander effect). 2) SHR-A1921: TROP2-directed ADC targeting TACSTD2 on epithelial tumor cells, same ADC mechanism. 3) SHR-A2009: HER3-directed ADC targeting ERBB3, same ADC mechanism. 4) SHR-A2102: Nectin-4–directed ADC targeting PVRL4, same ADC mechanism. 5) Famitinib: oral small-molecule multi-kinase TKI inhibiting VEGFR (±PDGFR/c-KIT), blocking tumor angiogenesis, tested with SHR-A1811. 6) Fat Module (MCT) supplement: induces nutritional ketosis, elevating beta-hydroxybutyrate to modulate tumor/host metabolism, tested with SHR-A1811. Targets: HER2/HER3/TROP2/Nectin-4–positive tumor cells, VEGF-driven vasculature, and metabolic pathways.