eligibility_summary
Adults (≥18) with histologically confirmed TNBC that is locally advanced unresectable or metastatic, eligible for sacituzumab govitecan monotherapy after ≥2 prior systemic lines (≥1 in advanced setting). Tumor tissue sample available, consented, and able to follow procedures. Excludes: history of other cancers, contraindications to SG, and untreated or symptomatic/unstable brain metastases.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial type: Prospective, multicenter observational study in metastatic triple‑negative breast cancer (mTNBC) patients receiving sacituzumab govitecan (SG) in routine care, with biomarker discovery in tumor tissue and plasma, feasibility of organoids and single‑cell sequencing in a subset. Drug/intervention: Sacituzumab govitecan (Trodelvy) is an antibody–drug conjugate (ADC): a humanized anti–Trop‑2 IgG1 linked via a cleavable linker to SN‑38, the active metabolite of irinotecan (a topoisomerase I inhibitor). Mechanism of action: SG binds Trop‑2 on tumor cells, is internalized, and releases SN‑38, inhibiting topoisomerase I, causing DNA damage and cell death, cleavable linker can enable a bystander effect. Targets (cells/pathways): Trop‑2–expressing TNBC cells, topoisomerase I/DNA replication and repair pathways, leading to cell‑cycle arrest/apoptosis. Intervention in study: data collection and biomarker analyses.