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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ONCOTYPEDX Test
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Oncotype DX, Adjuvant! Online, Decisional Conflict Scale

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Simcoe Muskoka Cancer Program - Royal Victoria Hospital
  • Quinte Healthcare Corporation
  • William Osler Health Centre
  • Brantford General Hospital
  • Joseph Brant Hospital
  • Cambridge Memorial Hospital
  • Juravinski Cancer Centre
  • Cancer Centre of Southeastern Ontario at Kingston
  • Grand River Regional Cancer Centre
  • London Regional Cancer Centre
  • Markham Stouffville Hospital
  • The Credit Valley Hospital
  • Stronach Regional Cancer Centre
  • R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
  • The Ottawa Hospital Regional Cancer Centre
  • Grey Bruce Health Services
  • Peterborough Regional Health Centre
  • Mackenzie Health
  • Bluewater Health
  • Algoma District Cancer Program - Sault Area Hospital
  • Rouge Valley Health System
  • The Scarborough Hospital
  • Niagara Health System
  • Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
  • Thunder Bay Regional Health Sciences Centre
  • North York General Hospital
  • Toronto East General Hospital
  • Sunnybrook Health Sciences - Odette Cancer Centre
  • St. Michael's Hospital
  • Mount Sinai Hospital
  • Princess Margaret Hospital
  • St. Joseph's Healthcare
  • Trillium Health Centre
  • Humber River Regional Cancer Centre
  • Windsor Regional Cancer Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Early Stage Breast Cancer

Arm Description

Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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®.

Full Information

First Posted
August 24, 2011
Last Updated
March 26, 2014
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT01423890
Brief Title
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
Acronym
ONCOTYPEDX
Official Title
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Oncotype DX, Adjuvant! Online, Decisional Conflict Scale

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1011 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Stage Breast Cancer
Arm Type
Other
Arm Description
Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
Intervention Type
Genetic
Intervention Name(s)
ONCOTYPEDX Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in treatment recommendation
Description
The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Association between Oncotype DX® RS with other estimated risk calculations
Description
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.
Time Frame
One month
Title
Change in patient decisional conflict
Description
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.
Time Frame
One month
Title
Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Description
To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark N. Levine, MD
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simcoe Muskoka Cancer Program - Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Quinte Healthcare Corporation
City
Belleville
State/Province
Ontario
ZIP/Postal Code
K8N 5A9
Country
Canada
Facility Name
William Osler Health Centre
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Brantford General Hospital
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 1G9
Country
Canada
Facility Name
Joseph Brant Hospital
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7S 1W7
Country
Canada
Facility Name
Cambridge Memorial Hospital
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 3G2
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Grand River Regional Cancer Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Markham Stouffville Hospital
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
Facility Name
The Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Stronach Regional Cancer Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Grey Bruce Health Services
City
Owen Sound
State/Province
Ontario
ZIP/Postal Code
N4K 6M9
Country
Canada
Facility Name
Peterborough Regional Health Centre
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 7C6
Country
Canada
Facility Name
Mackenzie Health
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 4Z3
Country
Canada
Facility Name
Bluewater Health
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 6S3
Country
Canada
Facility Name
Algoma District Cancer Program - Sault Area Hospital
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
Rouge Valley Health System
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1E 5E9
Country
Canada
Facility Name
The Scarborough Hospital
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
Facility Name
Niagara Health System
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2R 7C6
Country
Canada
Facility Name
Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Sunnybrook Health Sciences - Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada
Facility Name
Trillium Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9C 1A5
Country
Canada
Facility Name
Humber River Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Windsor Regional Cancer Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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