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

Summary

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.

Conditions

• HER2-positive Breast Cancer
• Early-stage Breast Cancer

Interventions

DEVICE

Personalized treatment according to molecular diagnosis with HER2DX

Patients with HER2DX high-risk disease: * Neoadjuvant treatment: * High HER2DX pCR score: paclitaxel per 12 weeks + trastuzumab +/- pertuzumab per 4-5 cycles. * Medium HER2DX pCR score: carboplatin + paclitaxel per 12-18 (or docetaxel per 4-6 cycles) + trastuzumab +/- pertuzumab per 4-7 cycles. * Low HER2DX pCR score: standard of care neoadjuvant CT regimens and HER2 blockade at the investigator's choice. * Adjuvant treatment: * pCR at surgery; Trastuzumab +/- pertuzumab up to a total of 18 cycles (including neoadjuvant and adjuvant therapy). * No pCR at surgery: T-DM1 per 14 cycles. Patients with HER2DX low-risk disease: * Neoadjuvant treatment: paclitaxel per 12 weeks + trastuzumab +/- pertuzumab per 4-5 cycles. * Adjuvant treatment will be according to the pCR status at surgery: * pCR at surgery: trastuzumab or no adjuvant treatment. * No pCR at surgery: trastuzumab or T-DM1.

OTHER

Treatment by physician´s choice, blinded to the diagnostic HER2DX test results

Patients randomized in ARM A will be treated with standard of care neoadjuvant CT regimens and HER2 blockade at the investigator's choice validated by national and/or international guidelines.

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group

  collaborator OTHER

• Austrian Breast & Colorectal Cancer Study Group

  collaborator NETWORK

• UNICANCER

  collaborator OTHER

• Westdeutsche Studiengruppe GmbH (WSG)

  collaborator UNKNOWN

• Istituto Oncologico Veneto IRCCS

  collaborator OTHER

• University College Cork

  collaborator OTHER

• University of Padova

  collaborator OTHER

• Istituto Europeo di Oncologia

  collaborator OTHER

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• The Sheba Fund for Health Services and Research

  collaborator UNKNOWN

• Erasmus University Rotterdam

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Institut Català d'Oncologia

  collaborator OTHER

• Europa Donna

  collaborator UNKNOWN

• Reveal Genomics

  collaborator UNKNOWN

• Fundacio Clinic Barcelona

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-11

Primary Completion

2028-11-30

Completion

2028-11-30

Countries

• Austria
• France
• Israel
• Italy
• Spain

Study Locations