A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
ONCOTYPEDX
1 other identifier
interventional
1,011
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jan 2012
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 27, 2014
March 1, 2014
2.1 years
August 24, 2011
March 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Association between Oncotype DX® RS with other estimated risk calculations
One month
Change in patient decisional conflict
One month
Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
6 months
Study Arms (1)
Early Stage Breast Cancer
OTHERWomen and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Simcoe Muskoka Cancer Program - Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
Quinte Healthcare Corporation
Belleville, Ontario, K8N 5A9, Canada
William Osler Health Centre
Brampton, Ontario, L6R 3J7, Canada
Brantford General Hospital
Brantford, Ontario, N3R 1G9, Canada
Joseph Brant Hospital
Burlington, Ontario, L7S 1W7, Canada
Cambridge Memorial Hospital
Cambridge, Ontario, N1R 3G2, Canada
Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
Greater Sudbury, Ontario, P3E 5J1, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 1C3, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Markham Stouffville Hospital
Markham, Ontario, L6B 1A1, Canada
The Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Stronach Regional Cancer Centre
Newmarket, Ontario, L3Y 2P9, Canada
R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Grey Bruce Health Services
Owen Sound, Ontario, N4K 6M9, Canada
Peterborough Regional Health Centre
Peterborough, Ontario, K9J 7C6, Canada
Mackenzie Health
Richmond Hill, Ontario, L4C 4Z3, Canada
Bluewater Health
Sarnia, Ontario, N7T 6S3, Canada
Algoma District Cancer Program - Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Rouge Valley Health System
Scarborough Village, Ontario, M1E 5E9, Canada
The Scarborough Hospital
Scarborough Village, Ontario, M1P 2T7, Canada
Niagara Health System
St. Catharines, Ontario, L2R 7C6, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
North York General Hospital
Toronto, Ontario, M2K 1E1, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Sunnybrook Health Sciences - Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
St. Joseph's Healthcare
Toronto, Ontario, M6R 1B5, Canada
Trillium Health Centre
Toronto, Ontario, M9C 1A5, Canada
Humber River Regional Cancer Centre
Toronto, Ontario, M9N 1N8, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark N. Levine, MD
Ontario Clinical Oncology Group (OCOG)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 26, 2011
Study Start
January 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 27, 2014
Record last verified: 2014-03