Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study

This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.

Trial Details

NCT ID
NCT06162559
Phase
PHASE1
Sponsor
The Netherlands Cancer Institute
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Tucatinib
  • Trastuzumab
  • Pertuzumab
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969

Key Eligibility Criteria

  • Signed written informed consent
  • Histologically confirmed primary invasive breast cancer
  • Stage II - IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter on DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 c…
  • HER2 overexpression defined as circumferential membrane staining that is complete, intense and in \>10% of invasive tumor cells (IHC 3+) on pre-tre…

For full eligibility, visit ClinicalTrials.gov.

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