eligibility_summary
Eligible: unresectable/metastatic HR+/HER2- breast cancer with progression after ≥1 endocrine line incl a CDK4/6 combo, chemotherapy candidate, ECOG 0–1, adequate organ function, controlled HIV, HBV on antivirals with undetectable load, HCV RNA undetectable. Exclude: curable disease, relapse <6 mo after adju/neoadj chemo, symptomatic visceral crisis, prior chemo for advanced disease, active autoimmune (past 2y), pneumonitis/ILD, active systemic infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 trial in HR+/HER2− unresectable/metastatic breast cancer. Interventions: 1) Sacituzumab tirumotecan (MK‑2870): TROP2‑directed antibody‑drug conjugate (ADC) carrying a topoisomerase‑I inhibitor, binds TROP2 on tumor cells, is internalized, releases payload to cause DNA damage/replication stress (with bystander effect). 2) Pembrolizumab (MK‑3475): anti–PD‑1 monoclonal antibody (immune checkpoint inhibitor) restoring T‑cell activity by blocking PD‑1–PD‑L1/PD‑L2. Tested as MK‑2870 alone or with pembrolizumab vs Treatment of Physician’s Choice: paclitaxel or nab‑paclitaxel (taxane microtubule stabilizers), capecitabine (5‑FU prodrug, thymidylate synthase inhibition), liposomal doxorubicin (anthracycline, DNA intercalation/topoisomerase‑II inhibition). Targets/pathways: TROP2, PD‑1/PD‑L1 axis, microtubules, thymidylate synthase, topoisomerase II, DNA integrity.