eligibility_summary
Adults (≥18) with unresectable/metastatic HR+ HER2-low breast cancer, endocrine-refractory, prior CDK4/6 inhibitor and 1-4 prior metastatic chemo lines, prior T-DXd allowed, progression, measurable disease, ECOG 0-2, adequate labs/organ function, required washouts, contraception as applicable. Exclude: candidates for curative stage IIIc, active/symptomatic brain mets, serious infection, irinotecan anaphylaxis, pregnant/breastfeeding, recent investigational therapy, other high-risk conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06263543 tests sacituzumab govitecan (SG, Trodelvy), an antibody–drug conjugate (ADC). Mechanism: a humanized anti–TROP‑2 monoclonal antibody delivers the cytotoxic payload SN‑38 (the active metabolite of irinotecan), a topoisomerase I inhibitor. After binding TROP‑2 on tumor cells, the ADC is internalized and releases SN‑38, causing DNA damage and apoptosis with a bystander effect. Target cells/pathways: ER+/HER2‑low metastatic breast cancer cells expressing TROP‑2, the payload inhibits the topoisomerase I DNA replication/repair pathway. Context: patients have previously received trastuzumab deruxtecan (T‑DXd), an anti‑HER2 ADC with a topoisomerase I payload (DXd), but only SG is administered in this study.