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A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer

The evidence supporting the adoption of Oncotype DX® is relatively weak by the criteria used
by the Ontario Health Technology Advisory Committee (OHTAC). There is only one small
published prospective study that reports on Oncotype DX® changing clinical management. The
economic models that estimated the potential advantages of using an Oncotype DX® guided
treatment strategy may have overestimated the benefits because they assumed that all
patients with tumors >1cm in the absence of Oncotype DX® testing would receive chemotherapy
in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen
is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute
benefit of 28%. (The benefit comes from one trial and is applied to all patients). It is
estimated that there are about 3,300 incident cases with node negative, ER positive, HER2
neu negative tumors annually in Ontario, it is important to evaluate the adoption of this
test for decision making in Ontario.

Inclusion Criteria:

- Women or men with histologic evidence of invasive breast cancer (ductal, lobular or
mixed disease).

- Surgical resection including breast conserving surgery or modified radical mastectomy
or simple mastectomy, within the last four months.

- Axillary lymph nodes assessed for tumor by:

(i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both

- Axillary lymph node assessment negative for cancer, or positive only for
micrometastases (i.e., cancer <2mm by H&E stain).

- Tumor is estrogen receptor (ER) positive.

- Receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase

- Being considered for adjuvant chemotherapy.

Exclusion Criteria:

- Axillary lymph node positive for cancer.

- Patients with inoperable locally advanced breast cancer.

- Metastatic breast cancer, including local ipsilateral recurrence.

- HER2 neu positive.

- Physician/Patient unwilling to comply with study protocol.

- Inability to provide informed consent (e.g. dementia or severe cognitive impairment).

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Change in treatment recommendation

Outcome Description:

The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.

Outcome Time Frame:

One month

Safety Issue:


Principal Investigator

Mark N. Levine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ontario Clinical Oncology Group (OCOG)


Canada: Ministry of Health & Long Term Care, Ontario

Study ID:




Start Date:

January 2012

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Oncotype DX
  • Adjuvant! Online
  • Decisional Conflict Scale
  • Breast Neoplasms