eligibility_summary
Eligible: adults (≥18) with HER2-positive breast cancer who completed concurrent IV pertuzumab+trastuzumab chemotherapy, are on/planned for maintenance PH FDC SC per label, expect ≥6 remaining cycles, and provide informed consent. Exclude: life expectancy <6 months, any PH FDC SC contraindication per Italian SmPC, participation in another trial, or <6 remaining cycles.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: Fixed‑dose subcutaneous combination of pertuzumab + trastuzumab (biologic monoclonal antibodies, maintenance after prior IV P+T). SC formulation contains recombinant human hyaluronidase to enhance tissue dispersion/absorption (no antitumor activity). Mechanisms of action: Trastuzumab (IgG1) binds HER2 extracellular domain IV, inhibits HER2 signaling and receptor shedding, and triggers antibody‑dependent cellular cytotoxicity (ADCC). Pertuzumab (IgG1) binds HER2 domain II, blocks HER2 dimerization—especially HER2:HER3—thereby suppressing downstream PI3K/AKT and MAPK pathways, also mediates ADCC. Cells/pathways targeted: HER2‑overexpressing breast cancer cells, HER2/HER3 heterodimers, downstream PI3K/AKT and MAPK signaling, engagement of immune effector cells (e.g., NK cells via Fcγ receptors). Observational study focused on real‑world safety during maintenance therapy.