eligibility_summary
Adults with HR+, HER2− metastatic/locally recurrent breast cancer: RECIST progression, tumor tissue available, ECOG 0–1, adequate organs, candidates for first chemo (capecitabine, nab‑paclitaxel, or paclitaxel). Must be ET‑resistant (≥2 prior ET lines, early adjuvant relapse, or 1st‑line ET±CDK4/6 failure), prior targeted agents allowed, no further ET options. Exclude prior topo‑I or Trop‑2 ADCs, recent investigational use, curative Stage IIIc, relapse ≤6 mo post (neo)adjuvant chemo, active infection/HBV/HCV, active 2nd cancer, pregnancy/breastfeeding, well‑controlled HIV on ART allowed, Kaposi/MCD excluded.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized, open-label trial in HR+/HER2- (including HER2-low) metastatic breast cancer after endocrine therapy. Interventions: sacituzumab govitecan-hziy (Trodelvy, antibody-drug conjugate) vs treatment of physician’s choice: paclitaxel (taxane), nab-paclitaxel (albumin-bound taxane), or capecitabine (oral prodrug of 5-FU). Mechanisms/targets: Sacituzumab govitecan targets Trop-2 on breast cancer cells, upon internalization it releases SN-38 (topoisomerase I inhibitor), causing DNA damage and tumor cell death, with potential bystander effect. Paclitaxel/nab-paclitaxel stabilize microtubules, blocking mitosis in rapidly dividing cells. Capecitabine is converted to 5-FU, inhibiting thymidylate synthase and RNA/DNA synthesis in proliferating cells. Primary efficacy focus: progression-free survival.