(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer

Breast Cancer Clinical Trial

Official title: A Prospective Clinical Utility Study of the Impact of the 21 Gene Recurrence Score® Assay (Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer in Multiple BC Cancer Agency Centres

Status Recruiting

Clinical Trial Summary

This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. The study also has a pharmacoeconomic component.

Clinical Trial Description

This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The study also has a pharmacoeconomic component. All eligible patients in which either physician and/or patient determine that results from the 21 gene recurrence score could provide additional information useful in the decision making process regarding adjuvant chemotherapy or not will be asked by the participating physicians to participate in the study. If interested, the patient will consent to the study. The physician will complete a baseline questionnaire to document recommended adjuvant systemic therapies (pre-Oncotype DX®). The Oncotype DX® assay will be ordered after receipt of the Physician and Patient Registration and assignment of patient study number. The physician will discuss the results of the Oncotype DX® assay with the patient once the result is available and upon receipt of the pre-test questionnaire. The physician will complete a follow-up questionnaire (to document recommended adjuvant systemic therapies post Oncotype DX®) after the result of the Oncotype DX® assay is known. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02627703
• Study type: Observational
• Source: British Columbia Cancer Agency
• Contact: Stephen Chia, MD
• Phone: 604-877-6000
• Email: schia@bccancer.bc.ca
• Status: Recruiting
• Phase: N/A
• Start date: May 2010