NCT02773004

Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	EPClin genomic test

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2016-05-16
• Last updated: 2023-09-01