- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have undergone surgical treatment for breast cancer with adequate evaluation of lymph node status with a sentinel lymph node procedure or full axillary dissection, with positive involvement of 1-3 axillary lymph nodes as confirmed by histologic examination.
- ECOG performance status 0 or 1
- Patient must be a candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy
- Eligible Staging Criteria: T1-3 N1 M0
- Breast tumor must undergo central pathology review at GHI and must be found adequate for the Oncotype DX assay.
- Breast tumor must be estrogen-receptor positive and HER2 positive (IHC/FISH) as per institutional guidelines
Exclusion Criteria:
- Patient has a prior history of breast cancer in the same breast
- Patient as been newly diagnosed with more than one operable primary breast tumor
- Patient has multi-centric tumors (note: patients with multi-focal tumors may be included)
- Patient has known metastatic breast cancer
- Patient has <2mm invasive tumor as assessed by local pathologist
- Patient has received any kind of neoadjuvant treatment
- Presence of clinical factors rendering the patient a non-viable candidate for adjuvant chemotherapy
- Presence of a current medical condition that would interfere with patient's ability to consent and participate in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early stage breast cancer
Women with node positive (1-3 nodes), ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy. Study subjects will have ONCOTYPE Dx assay performed on their breast tumors, and will complete study questionnaires. |
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in physicians' treatment recommendations
Time Frame: 2-4 weeks
|
2-4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient's treatment preference and level of confidence in treatment plan
Time Frame: 2-4 weeks
|
2-4 weeks
|
|
Change in physicians' level of confidence in the treatment recommendation
Time Frame: 2-4 weeks
|
2-4 weeks
|
|
Specific chemotherapy and/or hormone therapy regimen received by patient
Time Frame: 4-8 weeks
|
Assessment of actual adjuvant treatment given to patient after Oncotype DX results available
|
4-8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrea Eisen, MD, Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 231-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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