Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer (DEFINITIVE)

NCT06446882 NA RECRUITING

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.

Details

Lead sponsor	Fundacio Clinic Barcelona
Phase	NA
Status	RECRUITING
Enrolment	304
Start date	2024-10-11
Completion	2028-11

Conditions

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

Interventions

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

Primary outcomes

• Global health status (GHS) scale from the EORTC QLQ-C30 questionnaire — Up to 5 years
  The GHS scale is based on two 7-point questions (from very poor to excellent, items 29-30 from EORTC QLQ-C30 questionnaire). Following EORTC scoring manuals, a linear transformation will be used to standardize the GHS scale to a 0-100 scale.
• Score from the FACIT Fatigue Scale — Up to 5 years
  The FACIT Fatigue Scale, version 4 will be used to evaluate PRO measures of quality-of-life concerns related to fatigue. The FACIT Fatigue Scale is a 13-item questionnaire designed to measure fatigue and its impact on daily life in individuals with various health conditions. Respondents rate their fatigue experiences over the past week on a scale from 0 to 4, with higher scores indicating less fatigue. The total score ranges from 0 to 52.

Countries

Austria, France, Israel, Italy, Spain