Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer (ADENDOM)
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|ClinicalTrials.gov Identifier: NCT02773004|
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : October 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: EPClin genomic test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||December 2017|
EndoPredict (EP)clin testing
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.
Other: EPClin genomic test
- The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result [ Time Frame: 15 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773004
|Study Chair:||Frédérique Penault-Llorca, MD, PhD||Centre Jean Perrin, Clermont Ferrand, France|
|Principal Investigator:||Suzette Delaloge, MD||Gustave Roussy, Villejuif, France|