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Brief Title: A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
Official Title: A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
Study ID: NCT01423890
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
North York General Hospital, Toronto, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Sunnybrook Health Sciences - Odette Cancer Centre, Toronto, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
St. Joseph's Healthcare, Toronto, Ontario, Canada
Trillium Health Centre, Toronto, Ontario, Canada
Humber River Regional Cancer Centre, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Name: Mark N. Levine, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: PRINCIPAL_INVESTIGATOR