eligibility_summary
Adults (≥18) with unresectable or recurrent/metastatic HR+HER2− breast cancer after 1–2 chemo lines plus endocrine, CDK4/6i and taxane, progressive, RECIST‑measurable disease, ECOG 0–1, adequate organs, LVEF ≥50%, tissue available, negative pregnancy/contraception. Exclude prior topo‑I or EGFR/HER3 ADCs, recent therapy, high anthracycline, cardiac/vascular disease, ILD or CNS metastases, uncontrolled HTN/DM, active infection/immunosuppression, bleeding/GI disease, investigational drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, randomized trial in unresectable/metastatic HR+HER2– breast cancer post ≥1 chemo. Experimental: BL-B01D1 (izalontamab brengitecan, BMS-986507), an EGFR/HER3 bispecific antibody–drug conjugate carrying a topoisomerase I inhibitor (brengitecan). Mechanism: binds EGFR/HER3 on tumor cells, internalizes, releases topo I inhibitor to cause DNA strand breaks and bystander killing. Targets: EGFR/HER3 (ErbB)–expressing cells, DNA replication/repair via topo I. Control (physician’s choice): eribulin (microtubule dynamics inhibitor, halichondrin analog), vinorelbine (vinca alkaloid microtubule inhibitor), gemcitabine (deoxycytidine antimetabolite, inhibits ribonucleotide reductase and DNA incorporation), capecitabine (oral 5-FU prodrug, inhibits thymidylate synthase, RNA/DNA incorporation). Pathways targeted: EGFR/HER3 signaling, mitotic microtubules, and DNA synthesis/repair.