eligibility_summary
Adults ≥18, ECOG ≤2, with unresectable/metastatic TNBC after ≥2 prior systemic lines (≥1 metastatic) or HR+/HER2− (IHC 0/1+ or 2+/ISH−) after endocrine therapy + ≥2 systemic lines. Must have received gosatetuzumab for advanced disease, adhere to protocol, and use contraception. Excludes pregnant/lactating, serious infection/comorbidity, other malignancy ≤5y (standard exceptions), psychiatric noncompliance, major organ failure, gosatetuzumab allergy, non‑PD regimen change, other investigator concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06966141 (recruiting, observational, China) evaluates real‑world effectiveness and safety of sacituzumab govitecan (SG) in metastatic HER2‑negative breast cancer (TNBC and HR+/HER2‑ after prior therapies). Drug/intervention: Sacituzumab govitecan is an antibody–drug conjugate (ADC). It consists of a humanized monoclonal antibody against Trop‑2 linked to SN‑38, the active metabolite of irinotecan, a cytotoxic topoisomerase I inhibitor. Mechanism: The anti–Trop‑2 antibody targets Trop‑2–expressing tumor cells, is internalized, and releases SN‑38 to inhibit topoisomerase I, causing DNA damage, cell‑cycle arrest, and apoptosis, a bystander effect may contribute. Cells/pathways targeted: Trop‑2–positive breast cancer cells, topoisomerase I/DNA replication and repair pathways.