eligibility_summary
Eligible: confirmed TNBC without relapse, completed KEYNOTE‑522 neoadjuvant, surgery with non‑pCR and recovery, can continue adjuvant pembrolizumab, randomize ≤16 wks post‑op, RT done if indicated. Exclude: BRCA (olaparib‑eligible), >G2 neuropathy, IBD, major CV/CVA, prior TROP2/topo‑I ADC, recent CPI/systemic therapy/RT/live vaccine/investigational use, other active cancer, immunodeficiency/high‑dose steroids, autoimmune dz, pneumonitis/ILD, active infection, HBV+HCV, prior allogeneic Tx.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: Sacituzumab tirumotecan (MK-2870), a TROP2-targeting antibody–drug conjugate with a topoisomerase I inhibitor payload, Pembrolizumab (MK-3475), an anti–PD-1 monoclonal antibody immune checkpoint inhibitor, Capecitabine, an oral prodrug of 5‑FU antimetabolite chemotherapy. Mechanisms/targets: MK-2870 binds TROP2 on TNBC tumor cells, is internalized, and releases a topo I inhibitor to cause DNA damage (potential bystander effect), Pembrolizumab blocks PD-1 on T cells, restoring antitumor T-cell activity via PD-1/PD-L1 pathway, Capecitabine → 5‑FU inhibits thymidylate synthase, disrupting DNA/RNA synthesis in rapidly dividing tumor cells. Design: MK-2870 + pembrolizumab vs pembrolizumab ± capecitabine, primary endpoint: invasive disease-free survival.