Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer

The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer. Patients randomized to arm A will receive adjuvant treatment by physician´s choice, blinded to the diagnostic HER2DX test results. Patients randomized to Arm B will receive personalized treatment according to HER2DX results.

Trial Details

NCT ID
NCT06446882
Phase
NA
Sponsor
Fundacio Clinic Barcelona
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Personalized treatment according to molecular diagnosis with HER2DX
  • Treatment by physician´s choice, blinded to the diagnostic HER2DX test results
Locations (sample)
  • Graz, Austria|47.06733,15.44197
  • Leoben, Austria|47.3765,15.09144
  • Linz, Austria|48.30639,14.28611
  • Salzburg, Austria|47.79941,13.04399
  • Sankt Pölten, Austria|48.20762,15.63725

Key Eligibility Criteria

  • Signed informed consent must be obtained prior to any trial-specific procedure. Note: Candidate patients in France must be affiliated to a Social S…
  • Male/female patients who are at least 18 years of age on the day of signing informed consent.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Eligible for any of the following drugs: taxane, carboplatin, trastuzumab, pertuzumab and T-DM1 therapy.

For full eligibility, visit ClinicalTrials.gov.

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