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

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01423890
First received: August 24, 2011
Last updated: March 26, 2014
Last verified: March 2014

August 24, 2011
March 26, 2014
January 2012
February 2014   (final data collection date for primary outcome measure)
Change in treatment recommendation [ Time Frame: One month ] [ Designated as safety issue: No ]
The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
Same as current
Complete list of historical versions of study NCT01423890 on ClinicalTrials.gov Archive Site
  • Association between Oncotype DX® RS with other estimated risk calculations [ Time Frame: One month ] [ Designated as safety issue: No ]
    The level of association between the Oncotype DX® RS with estimated recurrence risk calculated by Adjuvant! Online, as well as with traditional factors including tumor size, grade, and HER2 neu.
  • Change in patient decisional conflict [ Time Frame: One month ] [ Designated as safety issue: No ]
    The change in the level of patient decisional conflict measured by the Decisional Conflict Scale (DCS). Additionally, the DCS has three subscales: uncertainty, effective decision making, and factors contributing to uncertainty. The change in each of these subscales will also be measured.
  • Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.
  • Association between Oncotype DX® RS with other estimated risk calculations [ Time Frame: One month ] [ Designated as safety issue: No ]
    The level of association between the Oncotype DX® RS with estimated recurrence risk calculated by Adjuvant! Online, as well as with traditional factors including tumor size, grade, and HER2 neu.
  • Change in patient decisional conflict [ Time Frame: One month ] [ Designated as safety issue: No ]
    The change in the level of patient decisional conflict measured by the Decisional Conflict Scale (DCS). Additionally, the DCS has three subscales: uncertainty, effective decision making, and factors contributing to uncertainty. The change in each of these subscales will also be measured.
  • Change in physician satisfaction [ Time Frame: One monthe ] [ Designated as safety issue: No ]
    The change in the level of physician satisfaction with decision making as measured by the Provider Decision Process Assessment Instrument.
  • Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Not Provided
Not Provided
 
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer

A prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Genetic: ONCOTYPEDX Test
Gene signature test containing 21 genes (16 cancer-related genes, e.g., invasion, proliferation, ER, Her 2 and five reference genes) and generates an individualized recurrence score.
Early Stage Breast Cancer
Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
Intervention: Genetic: ONCOTYPEDX Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1011
February 2014
February 2014   (final data collection date for primary outcome measure)

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 inhibitor).
  • 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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01423890
OCOG-2011-ONCOTYPEDX
No
Ontario Clinical Oncology Group (OCOG)
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
Principal Investigator: Mark N. Levine, MD Ontario Clinical Oncology Group (OCOG)
Ontario Clinical Oncology Group (OCOG)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP