eligibility_summary
Eligible: adults ≥18 with path-confirmed inoperable/metastatic TNBC progressing after (neo)adjuvant/systemic therapy, prior taxane (±ICI/PARP if indicated), RECIST-measurable disease, biopsy-accessible lesion and consent, ECOG ≤2, life exp ≥12 wks, adequate organs, HBV/HCV per protocol, negative pregnancy/contraception, compliance. Exclude: recent trial, active CNS mets, recent other cancers, prior topo-I/ADC, major cardiac disease, severe infection/recent surgery, hypersensitivity, unresolved >G2 tox, high-dose steroids, uncontrolled HIV/illness, prohibited meds/anticancer therapy, pregnancy/breastfeeding, unable to comply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Sacituzumab govitecan (Trodelvy), an antibody-drug conjugate (ADC) comprising a humanized anti–Trop-2 IgG1 linked to SN-38 (the active metabolite of irinotecan, a topoisomerase I inhibitor). Mechanism: The antibody binds Trop-2 on tumor cells, is internalized, and releases SN-38 to inhibit topoisomerase I, inducing DNA single-strand breaks, replication arrest, and apoptosis, its hydrolyzable linker enables a local bystander effect. Targets: Trop-2–expressing triple-negative breast cancer (TNBC) cells, key pathways include Trop-2 antigen targeting and DNA replication/repair via topoisomerase I inhibition. Trial design: open-label, single-arm phase IIIB in less-pretreated metastatic/locally advanced TNBC progressing after chemotherapy ± immunotherapy, with efficacy and biomarker analyses.