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
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.
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.
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