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

Sponsor
Fundacio Clinic Barcelona
Study ID
NCT06446882
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized treatment according to molecular diagnosis with HER2DX — DEVICE
    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.
  • Treatment by physician´s choice, blinded to the diagnostic HER2DX test results — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jun 6, 2024
Start date
Oct 11, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
304 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Arm A: Treatment by physician´s choice without the diagnostic test results
    Treatment by physician´s choice, blinded to the diagnostic HER2DX test results
  • Experimental: Arm B: Personalized treatment according to molecular diagnosis with HER2DX
    Personalized treatment according to molecular diagnosis with non-blinded HER2DX results

Primary Outcome Measure

Global health status (GHS) scale from the EORTC QLQ-C30 questionnaire [ Time Frame: Up to 5 years ]

Central Contacts

Find similar trials

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials

Related Studies