Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacio Clinic Barcelona
About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent must be obtained prior to any trial-specific procedure. Note: Candidate patients in France must be affiliated to a Social Security System (or equivalent).
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.
Disqualifiers
Stage IV (metastatic) breast cancer.
Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, carboplatin, T-DM1, docetaxel or paclitaxel.
Patients with synchronous bilateral invasive breast cancer.
Prior systemic therapy for treatment of breast cancer.
Trial design
Treatments tested in this trial
- Personalized treatment according to molecular diagnosis with HER2DX
- Treatment by physician´s choice, blinded to the diagnostic HER2DX test results
Treatment groups
304 Participants
are divided into 2 treatment groupsLocations
29Austria
MUG-Univ.-Klinik für Frauenheilkunde und Geburtshilfe, Klinische Abteilung für Gynäkologie Graz Austria
Lkh Hochsteiermark-Leoben Leoben Austria
Ordensklinikum Linz, Barmherzige Schwestern, Bhs Linz Austria
Uniklinikum Salzburg Salzburg Austria
Sponsors and collaborators
Fundacio Clinic Barcelona
Lead sponsor
SOLTI Breast Cancer Research Group
Collaborator
Austrian Breast & Colorectal Cancer Study Group
Collaborator
UNICANCER
Collaborator
Westdeutsche Studiengruppe GmbH (WSG)
Collaborator
Istituto Oncologico Veneto IRCCS
Collaborator
University College Cork
Collaborator
University of Padova
Collaborator
Istituto Europeo di Oncologia
Collaborator
National University of Ireland, Galway, Ireland
Collaborator
The Sheba Fund for Health Services and Research
Collaborator
Erasmus University Rotterdam
Collaborator
Medical University of Vienna
Collaborator
Institut Català d'Oncologia
Collaborator
Europa Donna
Collaborator
Reveal Genomics
Collaborator
Source ClinicalTrials.gov