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

Breast Cancer Clinical Trial

— ONCOTYPEDX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423890
• Other study ID #: OCOG-2011-ONCOTYPEDX
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: March 26, 2014
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Simcoe Muskoka Cancer Program - Royal Victoria Hospital	Barrie	Ontario
Canada	Quinte Healthcare Corporation	Belleville	Ontario
Canada	William Osler Health Centre	Brampton	Ontario
Canada	Brantford General Hospital	Brantford	Ontario
Canada	Joseph Brant Hospital	Burlington	Ontario
Canada	Cambridge Memorial Hospital	Cambridge	Ontario
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston	Kingston	Ontario
Canada	Grand River Regional Cancer Centre	Kitchener	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	The Credit Valley Hospital	Mississauga	Ontario
Canada	Stronach Regional Cancer Centre	Newmarket	Ontario
Canada	R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health	Oshawa	Ontario
Canada	The Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	Grey Bruce Health Services	Owen Sound	Ontario
Canada	Peterborough Regional Health Centre	Peterborough	Ontario
Canada	Mackenzie Health	Richmond Hill	Ontario
Canada	Bluewater Health	Sarnia	Ontario
Canada	Algoma District Cancer Program - Sault Area Hospital	Sault Ste. Marie	Ontario
Canada	Rouge Valley Health System	Scarborough	Ontario
Canada	The Scarborough Hospital	Scarborough	Ontario
Canada	Niagara Health System	St. Catharines	Ontario
Canada	Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord	Sudbury	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Humber River Regional Cancer Centre	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	St. Joseph's Healthcare	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences - Odette Cancer Centre	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	Trillium Health Centre	Toronto	Ontario
Canada	Windsor Regional Cancer Centre	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in treatment recommendation	The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.	One month	No
Secondary	Association between Oncotype DX® RS with other estimated risk calculations	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.	One month	No
Secondary	Change in patient decisional conflict	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.	One month	No
Secondary	Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.	To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.	6 months	No