eligibility_summary
Eligible: adults ≥18, ECOG 0–2, histologically proven HER2+ invasive breast cancer, HER2-enriched (MammaPrint/BluePrint) within 90 days, planned curative surgery with axillary staging and neoadjuvant chemo, stage cT1c–T3, cN0–N2, no metastases, LVEF ≥50%, adequate organ function. Bilateral/multifocal allowed. Consent required, contraception/negative test. Controlled HIV/HBV/HCV allowed. Exclude: prior therapy, active infection, pregnancy/nursing, conflicting malignancy, inability to consent, major comorbidity, drug contraindication, sensory neuropathy >1, hypersensitivity, prisoners.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm neoadjuvant therapy for early-stage, HER2-positive (HER2-enriched by BluePrint) breast cancer. Interventions: - Taxane chemotherapy: paclitaxel, nab-paclitaxel, or docetaxel (small-molecule cytotoxics, microtubule-stabilizing mitotic inhibitors that block depolymerization, causing mitotic arrest/apoptosis). - Targeted biologics: trastuzumab (humanized IgG1 mAb to HER2 extracellular domain, inhibits signaling and mediates ADCC) and pertuzumab (humanized IgG1 mAb to HER2 subdomain II, blocks HER2/HER3 dimerization and mediates ADCC). Cells/pathways targeted: HER2-overexpressing breast tumor cells, HER2 receptor and HER2/HER3 dimerization, downstream PI3K/AKT/MAPK signaling, mitotic spindle/microtubules in proliferating cancer cells, engagement of immune effector cells (NK cell FcγR-mediated ADCC). SC fixed-dose combo with hyaluronidase may substitute IV mAbs (delivery aid).