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

NCT ID: NCT01423890

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1011 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

ONCOTYPEDX Test

Intervention Type: GENETIC

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.

Interventions

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.

Intervention Type: GENETIC

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark N. Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group (OCOG)

Locations

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

Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord

Greater Sudbury, 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 Village, Ontario, Canada

The Scarborough Hospital

Scarborough Village, Ontario, Canada

Niagara Health System

St. Catharines, 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

Countries

Canada

Other Identifiers

OCOG-2011-ONCOTYPEDX

Identifier Type: -

Identifier Source: org_study_id