eligibility_summary
Eligible: ECOG 0–1, advanced/metastatic breast cancer, HER2 IHC 0 (ISH−/untested), never HER2+, ≥1 RECIST 1.1 measurable lesion, progression after ≥1 chemo (HR+ also after ≥1 endocrine ± CDK4/6), adequate organ/bone marrow function, consent. Exclude: prior anti‑HER2, severe mAb allergy, recent therapy (≤4 wks, endocrine ≤2 wks), other malignancy <5y (except BCC/CIS), CNS leptomeningeal/active brain mets, immunosuppression/steroids, major CV/lung disease, HIV/active HBV/HCV, any unsafe condition.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05824325 (GALAXY) is a Phase Ib/II, two-arm study in advanced/metastatic breast cancer with HER2 ultra-low or no expression. Interventions: 1) SHR-A1811, a HER2-targeted antibody-drug conjugate (ADC). Mechanism: an anti-HER2 monoclonal antibody delivers an intracellular cytotoxic payload after antigen binding and internalization, causing tumor cell death, may also engage Fc-mediated effector functions. Targets: tumor cells expressing HER2 (even at very low levels), implicating the HER2 receptor pathway. 2) A TROP2-targeted ADC (drug name not specified). Mechanism: an anti-TROP2 monoclonal antibody delivers a cytotoxic payload upon internalization to kill cancer cells. Targets: TROP2-expressing tumor cells, affecting TROP2-associated signaling. Both ADCs act via antigen-directed delivery of chemotherapy to cancer cells, specific payload types are not specified in the record.