eligibility_summary
Include: PD‑L1+ (CPS≥10) inoperable recurrent/metastatic TNBC, ECOG 0–1, measurable disease, recent FFPE tumor, no prior systemic Tx for advanced disease (≥6 mo since curative Tx if recurrent), chemo‑eligible (paclitaxel/nab‑paclitaxel or gemcitabine‑carboplatin), adequate organ/marrow function, contraception. Exclude: uncontrolled illness/infection (HBV/HCV, poorly controlled HIV), other cancer <3y, active brain mets (treated stable ok), ILD, autoimmune disease, prior topo‑I ADC/TROP2, concurrent therapy, PD‑1/PD‑L1 or Dato‑DXd allergy, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III trial in PD-L1–positive unresectable/metastatic triple-negative breast cancer compares: 1) Datopotamab deruxtecan (Dato-DXd), an antibody-drug conjugate (ADC) targeting TROP2 on tumor cells, upon internalization it releases a topoisomerase I inhibitor (deruxtecan) causing DNA damage, combined with durvalumab, an anti–PD-L1 IgG1 immune checkpoint inhibitor that restores T-cell activity, versus 2) investigator’s-choice chemotherapy (paclitaxel or nab-paclitaxel, microtubule stabilizers, or gemcitabine, an antimetabolite, plus carboplatin, a DNA crosslinking platinum) plus pembrolizumab, an anti–PD-1 IgG4 checkpoint inhibitor. Targets/pathways: TROP2+ tumor cells, PD-1/PD-L1 axis to activate cytotoxic T cells, and proliferating cells via microtubules/DNA synthesis/crosslinks. Includes a Dato-DXd monotherapy arm.