Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment epclin genomic test
Sponsor UNICANCER
Collaborator Myriad Genetics, Inc.
Start date December 2015
End date September 2016
Trial size 203 participants
Trial identifier NCT02773004, 2015-A00528-41, ADENDOM, PACS14, UC-0140/1505 - ADENDOM, UCBG 2-14

Summary

The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments.

Obtaining material for test is at no risk as done from the surgery material. Tumor molecular EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast cancer related genes and will provide important prognosis indications. Clinical validation studies have demonstrated that molecular assays are useful for stratifying patients into risk categories and helpful in making clinical treatment decisions in ER+/node-negative breast cancer patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
Once the patient is registered, the most representative block of the primary tumor from surgery (or 10 paraffin slides) are sent to the central analysis platform for EP clin testing. The EPclin method is based on analysis of tumour genes in combination with the classical prognostic factors of nodal status and tumour size.
epclin genomic test

Primary Outcomes

Measure
The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result
time frame: 15 days

Secondary Outcomes

Measure
Impact of genomic test results on patient's quality of life (QoL), anxiety levels and satisfaction results using standardized "State-Trait-Anxiety Inventory" questionnaires compared with general condition at baseline.
time frame: 1 year
Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results).
time frame: 1 year

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Age ≥ 18 years, - Performance status 0 or 1, - Patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer - Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery - Available surgical material (formalin-fixed, paraffin-embedded) for EPclin® evaluation - ER-positive by IHC (>10% cells stained or Allred Score≥4) - HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish - Node-negative or pN1mi (through axillary lymph node examination using sentinel node biopsy or axillary clearance) - Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined inthe following situations: - Lobular histology - Or grade II - Or grade III and pT < 2cm - Adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration - Willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest - Signed informed consent and Health insurance coverage Exclusion Criteria: - Non operable, bilateral, locally advanced, T4 or metastatic breast cancer - Any lymph node involvement with the exception of pN0i+ or pN1mi - HER2 Overexpression - Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma - Any previous systemic or locoregional treatment for the present breast cancer - Documented inherited predisposition with BRCA1/2 or TP53 mutation - Previous hormone replacement therapy (HRT) stopped less than 2 weeks before surgery - Previous treatment for the present breast cancer - Person unable to give informed consent

Additional Information

Official title Prospective Multicenter Study Assessing EndoPredict® (EP) Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments
Principal investigator Suzette Delaloge, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by UNICANCER.