eligibility_summary
Adults ≥18 with advanced/unresectable or metastatic TNBC (HER2−, ER/PR<10%), early relapse ≤12 months post (neo)adjuvant, prior PARPi if gBRCA, tumor tissue available, ECOG 0–2, LVEF≥50%, adequate organs, ≥1 RECIST lesion, washout, controlled brain/leptomeningeal mets allowed. Exclude: uncontrolled CNS, ILD/lung disease, major cardiac, active autoimmune/immunodeficiency, uncontrolled HBV/HCV/HIV, corneal disease, prior TROP2 ADC, severe allergy, concurrent therapy, pregnancy, contraception, no live vaccines/recent trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib/II modular trial in early-relapsed metastatic TNBC testing: 1) Datopotamab deruxtecan (Dato‑DXd), an antibody–drug conjugate (ADC) targeting TROP2, the anti‑TROP2 antibody delivers a topoisomerase I inhibitor (DXd) to TROP2‑expressing tumor cells, causing DNA damage and cell death (with potential bystander effect). 2) Dato‑DXd plus durvalumab, an anti‑PD‑L1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD‑L1 interactions to restore T‑cell antitumor immunity. Target cells/pathways: TROP2‑positive TNBC cells, topoisomerase I–mediated DNA replication, PD‑1/PD‑L1 axis on tumor and immune cells to enhance cytotoxic T‑cell responses.