Breast CancerONCOTYPEDXNCT01423890
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
A study testing ONCOTYPEDX Test in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 35 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ONCOTYPEDX Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 35 sitesCanada
- Study dates
- Jan 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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).
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Canada35 sites
Simcoe Muskoka Cancer Program - Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Quinte Healthcare Corporation
Belleville, Ontario, K8N 5A9
William Osler Health Centre
Brampton, Ontario, L6R 3J7
Brantford General Hospital
Brantford, Ontario, N3R 1G9
Joseph Brant Hospital
Burlington, Ontario, L7S 1W7
Cambridge Memorial Hospital
Cambridge, Ontario, N1R 3G2
Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
Greater Sudbury, Ontario, P3E 5J1
Juravinski Cancer Centre
Hamilton, Ontario, L8V 1C3
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
London Regional Cancer Centre
London, Ontario, N6A 4L6
Markham Stouffville Hospital
Markham, Ontario, L6B 1A1
The Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Stronach Regional Cancer Centre
Newmarket, Ontario, L3Y 2P9
R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
Oshawa, Ontario, L1G 2B9
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Grey Bruce Health Services
Owen Sound, Ontario, N4K 6M9
Peterborough Regional Health Centre
Peterborough, Ontario, K9J 7C6
Mackenzie Health
Richmond Hill, Ontario, L4C 4Z3
Bluewater Health
Sarnia, Ontario, N7T 6S3
Algoma District Cancer Program - Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8
Rouge Valley Health System
Scarborough Village, Ontario, M1E 5E9
The Scarborough Hospital
Scarborough Village, Ontario, M1P 2T7
Niagara Health System
St. Catharines, Ontario, L2R 7C6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
North York General Hospital
Toronto, Ontario, M2K 1E1
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Sunnybrook Health Sciences - Odette Cancer Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
St. Joseph's Healthcare
Toronto, Ontario, M6R 1B5
Trillium Health Centre
Toronto, Ontario, M9C 1A5
Humber River Regional Cancer Centre
Toronto, Ontario, M9N 1N8
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
About this study
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.
Read the 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
- Being tested
- ONCOTYPEDX Test
- Keywords
- Breast Cancer, Oncotype DX, Adjuvant! Online, Decisional Conflict Scale
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONCOTYPEDX TestGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Stage Breast Cancer | Other | Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy. Receives: Genetic: ONCOTYPEDX Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Secondary outcomes (3)
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.
Measured: One month
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.
Measured: One month
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®.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Mark N. Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423890
- Sponsor's protocol ID
- OCOG-2011-ONCOTYPEDX
- Acronym
- ONCOTYPEDX
- Status last verified
- Mar 2014
- First submitted
- 24 Aug 2011
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01423890
- Acronym / sponsor ID
- ONCOTYPEDX / OCOG-2011-ONCOTYPEDX
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Oncotype DX, Adjuvant! Online, Decisional Conflict Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Stage Breast Cancer | Other | Genetic: ONCOTYPEDX TestWomen and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONCOTYPEDX TestGene 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. | Genetic | Early Stage Breast Cancer |
Primary outcome
Change in treatment recommendation
Time frame: One month
The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
3 secondary outcomes
Association between Oncotype DX® RS with other estimated risk calculations
Time frame: One month
Change in patient decisional conflict
Time frame: One month
Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark N. Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONCOTYPEDX Test in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 35 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in treatment recommendation (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.