eligibility_summary
Eligible: 18–75, ECOG 0–1, unresectable LA/metastatic breast cancer with low HER2 (HR defined), path‑confirmed, progression, ≥1 RECIST lesion, adequate organ function. Exclude: other malignancy ≤5 y, unresolved >G1 toxicity, recent major surgery, significant pulm/CV disease or QTc↑, active infection, serious hepatic/renal disease, immunodeficiency/immunosuppression, recent anticancer tx, uncontrolled effusions/CNS mets, prior anti‑HER2, hypersensitivity to study drugs, investigator deems unsafe.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III randomized, open-label trial in HER2-low (IHC 1+ or 2+/ISH−), HR+ recurrent/metastatic breast cancer, chemo‑naive in the metastatic setting. Interventions: TQB2102 (next‑generation HER2‑targeted antibody–drug conjugate, IV) versus investigator’s choice chemotherapy (capecitabine, paclitaxel, or nab‑paclitaxel). Mechanisms: TQB2102 binds HER2 on tumor cells, is internalized, and releases a cytotoxic payload to kill HER2‑expressing cells (ADC). Capecitabine is an oral antimetabolite prodrug of 5‑FU that inhibits thymidylate synthase and DNA synthesis. Paclitaxel/nab‑paclitaxel are taxanes that stabilize microtubules, causing mitotic arrest. Targets/pathways: HER2‑expressing breast cancer cells, DNA synthesis (TS), microtubule dynamics in proliferating cells.