eligibility_summary
Adults ≥18, ECOG 0–1, HR+/HER2− unresectable locally advanced/metastatic breast cancer, CDK4/6‑refractory, ≤1 prior chemo/ADC for MBC, progression on last therapy, measurable/evaluable disease, lesion(s) amenable to serial biopsies, adequate organ function, life expectancy ≥16 wks, contraception. Exclude: HER2+ or TNBC, uncontrolled CNS mets, significant cardiac disease, IBD/perforation, serious infection, active HBV/HCV/HIV, recent live vaccine, prior sacituzumab, severe allergy, unresolved toxicities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06236269 (phase II, single-arm) in HR+/HER2- advanced/metastatic breast cancer after endocrine therapy and CDK4/6i. Intervention: Sacituzumab govitecan (Trodelvy), an antibody–drug conjugate (ADC). Mechanism: Humanized anti–Trop-2 IgG1 monoclonal antibody delivers SN-38 (the active metabolite of irinotecan), a topoisomerase I inhibitor. Binding to Trop-2 on tumor cells triggers internalization and hydrolyzable-linker release of SN-38, causing DNA damage and cell death, with a bystander effect due to membrane-permeable payload. Targeted cells/pathways: Trop-2–expressing breast cancer cells, topoisomerase I–dependent DNA replication machinery. Biomarker focus: change in CelTIL score (stromal tumor-infiltrating lymphocytes + tumor cellularity), reflecting tumor–immune microenvironment and tumor burden, exploratory ctDNA dynamics and resistance mechanisms. Dosage: 10 mg/kg IV D1,8 q21d until progression/toxicity.