NCT02347449

The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population

The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population of Patients With Estrogen Receptor- Positive Early Breast Cancer With 1-3 Positive Lymph Nodes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.

Detailed description

The Oncotype DX assay has been commercially available in the U.S. since 2004 as a tool to aid a physician's treatment recommendation for a breast cancer patient. While the Oncotype DX assay is currently reimbursed by the Ontario Health Ministry for node-negative EBC, it is not reimbursed for node-positive (N+) patients although the assay has been shown to be both prognostic and predictive of chemotherapy benefit for patients with N+ disease. The goal of this study is to characterize how the results of the Oncotype DX® assay impact the decision making processes of physicians and patients in a large academic medical center in Ontario by evaluating recommendations for adjuvant therapy within a population of ER+, N+ EBC patients with 1 to 3 positive lymph nodes for whom the benefit of adjuvant chemotherapy is not certain. Upon consent, the patient will be assigned an ID number. The physician will discuss the patient's treatment alternatives prior to ordering the Oncotype DX assay. After discussion with the patient, the physician will complete a baseline questionnaire indicating the therapeutic strategy he/she would recommend to the patient based upon the available clinical and pathologic data. In addition, the patient will also complete a baseline questionnaire indicating her treatment preference, based on the previous discussion with the physician. The Oncotype DX assay will be ordered after receipt of the Registration and Confirmation of Eligibility Form and assignment of patient study number. Once the results of the Oncotype DX assay are available, the physician will discuss the results with the patient. Both the physician and the patient will complete separate follow-up post-assay questionnaires after the results of the Oncotype DX assay are known and shared with the patient. One last form completed by a study manager or coordinator after a treatment plan has been initiated will register the actual treatment administered to the patient.

Conditions

• Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

Type	Name	Description
OTHER	Questionnaires, Oncotype Dx Assay	1. Physician pre-assay questionnaire 2. Patient pre-assay questionnaire 3. Oncotype DX® Assay 4. Physician post- assay questionnaire 5. Patient post-assay questionnaire

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2015-01-27
• Last updated: 2020-10-23

Locations

1 site across 1 country: Canada