eligibility_summary
Eligible: HR+ low-HER2 (IHC 2+/ISH- or 1+) metastatic breast cancer with radiologic progression and no longer benefiting from endocrine therapy, 0-1 prior metastatic chemo, measurable lesion, adequate cardiac/hematologic/renal/hepatic/coag function, WOCBP contraception and negative pregnancy test. Exclude: active CNS mets (stable treated allowed), HIV/active autoimmune, ILD/pneumonitis, moderate-severe CV disease, active HBV/HCV, other cancers within 5y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, randomized trial in HER2‑low recurrent/metastatic breast cancer. Interventions: • SHR-A1811 (experimental): a HER2‑targeted antibody–drug conjugate (biologic ADC). Mechanism: monoclonal antibody binds HER2 on tumor cells, is internalized, and releases a cytotoxic payload to kill HER2‑expressing cells, targets HER2 on breast cancer cells and downstream survival signaling via receptor-directed delivery. • Physician’s choice chemotherapy (active comparator): – Capecitabine (oral antimetabolite, 5‑FU prodrug inhibiting thymidylate synthase → blocks DNA synthesis). – Gemcitabine (antimetabolite nucleoside analog, inhibits DNA synthesis). – Eribulin (microtubule dynamics inhibitor, prevents microtubule growth). – Paclitaxel or nab‑paclitaxel (taxanes, stabilize microtubules). Targets/pathways: HER2 on tumor cells (SHR‑A1811), DNA replication pathways (capecitabine, gemcitabine), microtubule/cell-cycle machinery (eribulin, paclitaxel/nab‑paclitaxel).