Hormone Receptor Positive Malignant Neoplasm of BreastNCT02347449
The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population
A study testing Questionnaires, Oncotype Dx Assay in people with Hormone Receptor Positive Malignant Neoplasm of Breast, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor Positive Malignant Neoplasm of Breast
- What is being tested?
- Questionnaires, Oncotype Dx Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to 30 Sep 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have undergone surgical treatment for breast cancer with adequate evaluation of lymph node status with a sentinel lymph node procedure or full axillary dissection, with positive involvement of 1-3 axillary lymph nodes as confirmed by histologic examination.
- ECOG performance status 0 or 1
- Patient must be a candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy
- Eligible Staging Criteria: T1-3 N1 M0
- Breast tumor must undergo central pathology review at GHI and must be found adequate for the Oncotype DX assay.
- Breast tumor must be estrogen-receptor positive and HER2 positive (IHC/FISH) as per institutional guidelines
Who cannot join
- Patient has a prior history of breast cancer in the same breast
- Patient as been newly diagnosed with more than one operable primary breast tumor
- Patient has multi-centric tumors (note: patients with multi-focal tumors may be included)
- Patient has known metastatic breast cancer
- Patient has <2mm invasive tumor as assessed by local pathologist
- Patient has received any kind of neoadjuvant treatment
- Presence of clinical factors rendering the patient a non-viable candidate for adjuvant chemotherapy
- Presence of a current medical condition that would interfere with patient's ability to consent and participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population of Patients With Estrogen Receptor- Positive Early Breast Cancer With 1-3 Positive Lymph Nodes
The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.
Read the detailed description
The Oncotype DX assay has been commercially available in the U.S. since 2004 as a tool to aid a physician's treatment recommendation for a breast cancer patient. While the Oncotype DX assay is currently reimbursed by the Ontario Health Ministry for node-negative EBC, it is not reimbursed for node-positive (N+) patients although the assay has been shown to be both prognostic and predictive of chemotherapy benefit for patients with N+ disease.
The goal of this study is to characterize how the results of the Oncotype DX® assay impact the decision making processes of physicians and patients in a large academic medical center in Ontario by evaluating recommendations for adjuvant therapy within a population of ER+, N+ EBC patients with 1 to 3 positive lymph nodes for whom the benefit of adjuvant chemotherapy is not certain.
Upon consent, the patient will be assigned an ID number. The physician will discuss the patient's treatment alternatives prior to ordering the Oncotype DX assay. After discussion with the patient, the physician will complete a baseline questionnaire indicating the therapeutic strategy he/she would recommend to the patient based upon the available clinical and pathologic data. In addition, the patient will also complete a baseline questionnaire indicating her treatment preference, based on the previous discussion with the physician.
The Oncotype DX assay will be ordered after receipt of the Registration and Confirmation of Eligibility Form and assignment of patient study number. Once the results of the Oncotype DX assay are available, the physician will discuss the results with the patient. Both the physician and the patient will complete separate follow-up post-assay questionnaires after the results of the Oncotype DX assay are known and shared with the patient.
One last form completed by a study manager or coordinator after a treatment plan has been initiated will register the actual treatment administered to the patient.
- Being tested
- Questionnaires, Oncotype Dx Assay
- Keywords
- Early-stage Breast cancer, node positive, Prognosis, Oncotype Dx
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, Oncotype Dx AssayOther
Also called Oncotype Dx Assay, Questionnaires
- Physician pre-assay questionnaire
- Patient pre-assay questionnaire
- Oncotype DX® Assay
- Physician post- assay questionnaire
- Patient post-assay questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Early stage breast cancer | Experimental | Women with node positive (1-3 nodes), ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
Study subjects will have ONCOTYPE Dx assay performed on their breast tumors, and will complete study questionnaires. Receives: Other: Questionnaires, Oncotype Dx Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physicians' treatment recommendations
Measured: 2-4 weeks
Secondary outcomes (3)
Change in patient's treatment preference and level of confidence in treatment plan
Measured: 2-4 weeks
Change in physicians' level of confidence in the treatment recommendation
Measured: 2-4 weeks
Specific chemotherapy and/or hormone therapy regimen received by patient
Assessment of actual adjuvant treatment given to patient after Oncotype DX results available
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startOct 2014
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Responsible party
- Sponsor
- Investigators
- Andrea Eisen, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347449
- Sponsor's protocol ID
- 231-2014
- Status last verified
- Oct 2020
- First submitted
- 17 Nov 2014
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population of Patients With Estrogen Receptor- Positive Early Breast Cancer With 1-3 Positive Lymph Nodes
- ClinicalTrials.gov ID
- NCT02347449
- Acronym / sponsor ID
- 231-2014
- Keywords
- Early-stage Breast cancer, node positive, Prognosis, Oncotype Dx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Study start
- Oct 2014 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 27 Jan 2015 (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.
The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.
Detailed description
The Oncotype DX assay has been commercially available in the U.S. since 2004 as a tool to aid a physician's treatment recommendation for a breast cancer patient. While the Oncotype DX assay is currently reimbursed by the Ontario Health Ministry for node-negative EBC, it is not reimbursed for node-positive (N+) patients although the assay has been shown to be both prognostic and predictive of chemotherapy benefit for patients with N+ disease.
The goal of this study is to characterize how the results of the Oncotype DX® assay impact the decision making processes of physicians and patients in a large academic medical center in Ontario by evaluating recommendations for adjuvant therapy within a population of ER+, N+ EBC patients with 1 to 3 positive lymph nodes for whom the benefit of adjuvant chemotherapy is not certain.
Upon consent, the patient will be assigned an ID number. The physician will discuss the patient's treatment alternatives prior to ordering the Oncotype DX assay. After discussion with the patient, the physician will complete a baseline questionnaire indicating the therapeutic strategy he/she would recommend to the patient based upon the available clinical and pathologic data. In addition, the patient will also complete a baseline questionnaire indicating her treatment preference, based on the previous discussion with the physician.
The Oncotype DX assay will be ordered after receipt of the Registration and Confirmation of Eligibility Form and assignment of patient study number. Once the results of the Oncotype DX assay are available, the physician will discuss the results with the patient. Both the physician and the patient will complete separate follow-up post-assay questionnaires after the results of the Oncotype DX assay are known and shared with the patient.
One last form completed by a study manager or coordinator after a treatment plan has been initiated will register the actual treatment administered to the patient.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early stage breast cancer | Experimental | Other: Questionnaires, Oncotype Dx AssayWomen with node positive (1-3 nodes), ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy. Study subjects will have ONCOTYPE Dx assay performed on their breast tumors, and will complete study questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have undergone surgical treatment for breast cancer with adequate evaluation of lymph node status with a sentinel lymph node procedure or full axillary dissection, with positive involvement of 1-3 axillary lymph nodes as confirmed by histologic examination.
- ECOG performance status 0 or 1
- Patient must be a candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy
- Eligible Staging Criteria: T1-3 N1 M0
- Breast tumor must undergo central pathology review at GHI and must be found adequate for the Oncotype DX assay.
Key exclusion criteria (8 listed)
- Patient has a prior history of breast cancer in the same breast
- Patient as been newly diagnosed with more than one operable primary breast tumor
- Patient has multi-centric tumors (note: patients with multi-focal tumors may be included)
- Patient has known metastatic breast cancer
- Patient has <2mm invasive tumor as assessed by local pathologist
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 |
|---|---|---|
| Questionnaires, Oncotype Dx AssayAlso: Oncotype Dx Assay, Questionnaires1. Physician pre-assay questionnaire 2. Patient pre-assay questionnaire 3. Oncotype DX® Assay 4. Physician post- assay questionnaire 5. Patient post-assay questionnaire | Other | Early stage breast cancer |
Primary outcome
Change in physicians' treatment recommendations
Time frame: 2-4 weeks
3 secondary outcomes
Change in patient's treatment preference and level of confidence in treatment plan
Time frame: 2-4 weeks
Change in physicians' level of confidence in the treatment recommendation
Time frame: 2-4 weeks
Specific chemotherapy and/or hormone therapy regimen received by patient
Time frame: 4-8 weeks
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 23 Oct 2020.
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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.
Andrea Eisen, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Oncotype Dx Assay in people with Hormone Receptor Positive Malignant Neoplasm of Breast, run by Sunnybrook Health Sciences Centre at 1 site 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 6 inclusion and 8 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 physicians' treatment recommendations (time frame: 2-4 weeks). 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 23 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.