Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer (NCT06446882) | Clinical Trial Compass
RecruitingNot Applicable
Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer
Austria304 participantsStarted 2024-10-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed.
✓. Stage at presentation: cT1 cN1-2 or cT2-3 cN0-2 as determined by AJCC staging system, 8th edition (specifically in accordance with Anatomic Stage group rules).
✓. Absence of distant metastasis (i.e., cM0).
✓. Patients with multifocal tumors (more than one mass confined to the same quadrant as primary tumor) are eligible provided at least one focus is sampled and locally confirmed as HER2-positive.
Exclusion criteria
✕. 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.
What they're measuring
1
Global health status (GHS) scale from the EORTC QLQ-C30 questionnaire
✕. Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy.
✕. Patients with a history of previous breast cancer are excluded. Patients with a history of any other cancers (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years are excluded. For patients with a history of other non-breast cancerscancerscancers within 3 years and considered of low risk of recurrence per investigator's judgment (for example, papillary thyroid cancer treated with surgery), eligibility is to be discussed with the Sponsor.