eligibility_summary
Adults ≥18 with histologically/cytologically confirmed metastatic breast cancer previously treated systemically, ≥1 RECIST 1.1–measurable lesion, ECOG 0–1, willing to undergo serial 68Ga‑MY6349 PET/CT before/during Trop2‑ADC, able to consent. Exclude those with significant hepatic/renal impairment or life expectancy <3 months.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT07046689 is an observational study in metastatic breast cancer assessing whether 68Ga‑MY6349 PET/CT can predict response to Trop2‑targeted antibody–drug conjugates (Trop2‑ADCs). Interventions: 1) 68Ga‑MY6349 PET/CT (diagnostic test): a gallium‑68–labeled Trop2‑binding tracer that targets cell‑surface Trop2 and enables quantitative PET imaging (SUVmax/SUVmean). 2) Background therapy: Trop2‑ADCs (therapeutic monoclonal antibody–drug conjugates) that bind Trop2, internalize, and release a cytotoxic payload to kill Trop2‑positive tumor cells. Targets/pathways: Trop2 antigen on breast cancer cells, imaging of Trop2 expression/availability, ADC internalization and payload‑mediated tumor cell death. The study correlates early PET changes with RECIST response after two ADC cycles. Status: Recruiting (China).