Clinical trial NCT01423890: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Oncotype DX
Adjuvant! Online
Decisional Conflict Scale
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2011-08-26
Enrollment: 1011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: Change in treatment recommendation
timeFrame: One month
Secondary outcomes:
measure: Association between Oncotype DX® RS with other estimated risk calculations
timeFrame: One month
measure: Change in patient decisional conflict
timeFrame: One month
measure: Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
timeFrame: 6 months
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Simcoe Muskoka Cancer Program - Royal Victoria Hospital
state: Ontario
city: Belleville
country: Canada
facility: Quinte Healthcare Corporation
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Brantford
country: Canada
facility: Brantford General Hospital
state: Ontario
city: Burlington
country: Canada
facility: Joseph Brant Hospital
state: Ontario
city: Cambridge
country: Canada
facility: Cambridge Memorial Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville Hospital
state: Ontario
city: Mississauga
country: Canada
facility: The Credit Valley Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Stronach Regional Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Owen Sound
country: Canada
facility: Grey Bruce Health Services
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Regional Health Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: Mackenzie Health
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Health
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Algoma District Cancer Program - Sault Area Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Rouge Valley Health System
state: Ontario
city: Scarborough
country: Canada
facility: The Scarborough Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Sudbury
country: Canada
facility: Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences - Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Toronto
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Humber River Regional Cancer Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
Study officials:
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark N. Levine, MD
role: PRINCIPAL_INVESTIGATOR
References: