eligibility_summary
Eligible: ≥18 with stage IV triple‑negative breast cancer (ER/PR ≤10%, HER2‑neg by ISH/IHC), PD‑L1 CPS <10 or CPI‑ineligible, measurable disease (scans ≤28 d), ECOG ≤2, no prior metastatic chemo, adequate labs (ANC ≥1000, Plt ≥100k, liver ≤4× ULN, ≤6× if liver mets), contraception if fertile. Exclude: leptomeningeal disease, uncontrolled pain/hypercalcemia, recent other cancers, concurrent therapy, pregnancy/lactation, comorbidity/cardiac disease, major surgery <4 wks, psychiatric risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II randomized trial in metastatic triple‑negative breast cancer. Interventions: (1) Provider’s choice of standard cytotoxic chemotherapy (both arms) with conventional imaging, (2) In Arm B, serial blood-based ctDNA testing to guide an early therapy change, if ctDNA indicates nonresponse, patients may switch to sacituzumab govitecan IV. Mechanisms: ctDNA testing detects tumor-derived DNA in plasma and dynamics of tumor clones to signal treatment failure earlier than imaging. Sacituzumab govitecan is an antibody–drug conjugate: a humanized anti‑TROP2 monoclonal antibody (hRS7) delivering an irinotecan (topoisomerase I–inhibiting) payload to internalized cancer cells, causing DNA damage and death. Targets: TROP2 on TNBC cells, topoisomerase I, circulating tumor DNA reflecting tumor clones.