eligibility_summary
Eligibility: Adults (≥18) with pathology-proven TNBC and measurable brain mets (RANO-BM) not needing immediate local therapy, type II LMD allowed, KPS ≥70/ECOG ≤2, prior PD-1/PD-L1 or TROP-2 allowed, adequate organs. Controlled HBV/HCV allowed. Exclude: Dato-DXd allergy, recent investigational/other therapy or radiotherapy, other recent cancers, significant cardiac, renal/hepatic/pulmonary disease or ILD, uncontrolled HIV or infections, pregnancy/lactation, inadequate contraception, chronic steroids >8 mg dex, corneal disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, single-arm study of datopotamab deruxtecan (Dato‑DXd, DS‑1062a) in adults with triple‑negative breast cancer (TNBC) and newly diagnosed or progressing brain metastases. Intervention/mechanism: Dato‑DXd is an antibody–drug conjugate (ADC). The antibody is a humanized IgG1 targeting TROP2 (TACSTD2) on tumor cells, after binding and internalization, a cleavable linker releases the cytotoxic payload DXd (a topoisomerase I inhibitor), causing DNA damage, S‑phase arrest, and apoptosis, with a bystander effect. Dosing: 6.0 mg/kg IV every 3 weeks until progression or withdrawal. Cells/pathways targeted: TROP2‑overexpressing TNBC cells, including brain metastases, payload targets nuclear topoisomerase I–dependent DNA replication/repair pathways rather than TROP2 signaling per se. Primary endpoint: intracranial response by RANO‑BM.