eligibility_summary
Eligible: Women >18 with HER2-positive metastatic breast adenocarcinoma needing first-line trastuzumab+pertuzumab, PS 0–2, LVEF >50% within 12 weeks, life expectancy ≥3 months, consent. Exclude: prior systemic therapy for metastasis, ineligible for anti‑HER2, serious cardiac disease, hypersensitivity, uncontrolled CNS metastases, poor follow-up feasibility, pregnant or breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05698186 tests Thero2-01S22 as an add-on to first‑line HER2‑targeted therapy in metastatic HER2+ breast cancer. Interventions: Thero2-01S22 (investigational agent, dosing BID for 3 days around cycles, mechanism not disclosed) vs placebo, each combined with trastuzumab (monoclonal antibody blocking HER2 signaling and mediating ADCC) and pertuzumab (monoclonal antibody blocking HER2 dimerization), plus induction chemotherapy with a taxane (docetaxel/paclitaxel/nab‑paclitaxel, microtubule stabilizers) or vinorelbine (vinca alkaloid, microtubule destabilizer). Targets/pathways: HER2-overexpressing tumor cells, HER2 signaling and dimerization, immune effector ADCC, microtubule apparatus in proliferating cells, study rationale also addresses HER2–VEGF crosstalk/angiogenesis. Phase III, randomized, double‑blind, placebo‑controlled.