Breast CancerNCT02627703
(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer
An observational study of Breast Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Oncotype DX
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Dec 2017
- Phase
- Observational
- 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 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: * 18-79 years old * Operative Primary Breast Cancer * Node + (N1-3: micrometastasis) * ER + and HER 2- * Candidate for adjuvant chemotherapy in addition to hormonal therapy
Who may be able to join
- Operable breast cancer with the primary tumour (pT1-3)
- Pathological involvement (microscopic) of 1-3 lymph nodes. No minimum number of total lymph nodes need be resected. Extra-nodal extension of nodal deposit is allowed.
- Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines
- Patient's tumor must undergo central review at GHI and there must be adequate material for the Oncotype DX® assay.
- Patient's tumor must contain estrogen receptors (ER+).
- Patient must be between the ages (inclusive) of 18-79.
- Patient must be able to give informed consent
- Patient has adequate performance status (PS ECOG 0,1 or Karnofsky ≥70) and be a medically fit candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy with no contra-indications to either systemic therapy maneuvers
Who cannot join
- Patients have ER negative tumors (ER-) by local or central BCCA assessment
- Patients have HER2 positive tumors by local or central BCCA assessment
- Patients have four or more lymph node positive disease.
- Lymph node involvement by isolated tumor cells or cells by IHC only (less than 200 cells and/or ≤0.2 mm)
- Patients have known metastatic breast cancer.
- Patients are unable to give consent or understand written language.
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- Patients with poor performance status (ECOG 2-4) in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated.
- Pregnant women in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated.
- Patients with tumors that on GHI central pathological review appears inadequate for the Oncotype DX® assay.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z4E6
Stephen Chia, MD, 604-877-6000, schia@bccancer.bc.ca
About this study
Official title: A Prospective Clinical Utility Study of the Impact of the 21 Gene Recurrence Score® Assay (Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer in Multiple BC Cancer Agency Centres
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. The study also has a pharmacoeconomic component.
Read the detailed description
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The study also has a pharmacoeconomic component. All eligible patients in which either physician and/or patient determine that results from the 21 gene recurrence score could provide additional information useful in the decision making process regarding adjuvant chemotherapy or not will be asked by the participating physicians to participate in the study. If interested, the patient will consent to the study. The physician will complete a baseline questionnaire to document recommended adjuvant systemic therapies (pre-Oncotype DX®). The Oncotype DX® assay will be ordered after receipt of the Physician and Patient Registration and assignment of patient study number. The physician will discuss the results of the Oncotype DX® assay with the patient once the result is available and upon receipt of the pre-test questionnaire. The physician will complete a follow-up questionnaire (to document recommended adjuvant systemic therapies post Oncotype DX®) after the result of the Oncotype DX® assay is known.
- Conditions
- Breast Cancer
- Being tested
- 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.
Oncotype DXOther
The Oncotype DX® assay is a multi-gene reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test that analyzes the expression of 21 genes, and quantifies the 10 year distant breast cancer recurrence risk in patients with stage I and II, lymph node negative, estrogen receptor positive disease who plan to be treated with tamoxifen for 5 years.
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncotype DX® assay affect on physician's treatment recommendations assessed by questionnaire
The Oncotype DX® assay affect on physician's treatment recommendations pre and post Oncotype DX® Recurrence Score® result.
Measured: 1 Month
Secondary outcomes (1)
Assessing Costs differences to the Publicly funded Health Care System
Costs to a publicly funded health care system
Measured: Data will be analyzed within 8 weeks of enrollment completion and presented within 9 months of study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMay 2010
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627703
- Sponsor's protocol ID
- 01-168
- Status last verified
- Jul 2016
- First submitted
- 23 Nov 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Davidson JA, Cromwell I, Ellard SL, Lohrisch C, Gelmon KA, Shenkier T, Villa D, Lim H, Sun S, Taylor S, Taylor M, Czerkawski B, Hayes M, Ionescu DN, Yoshizawa C, Chao C, Peacock S, Chia SK. A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score(R) assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer. 2013 Jul;49(11):2469-75. doi: 10.1016/j.ejca.2013.03.009. Epub 2013 Apr 20.
PubMed 23611660
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Utility Study of the Impact of the 21 Gene Recurrence Score® Assay (Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer in Multiple BC Cancer Agency Centres
- ClinicalTrials.gov ID
- NCT02627703
- Acronym / sponsor ID
- 01-168
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Study start
- May 2010
- Primary completion
- Dec 2017 (estimated)
- First posted
- 11 Dec 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.
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. The study also has a pharmacoeconomic component.
Detailed description
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The study also has a pharmacoeconomic component. All eligible patients in which either physician and/or patient determine that results from the 21 gene recurrence score could provide additional information useful in the decision making process regarding adjuvant chemotherapy or not will be asked by the participating physicians to participate in the study. If interested, the patient will consent to the study. The physician will complete a baseline questionnaire to document recommended adjuvant systemic therapies (pre-Oncotype DX®). The Oncotype DX® assay will be ordered after receipt of the Physician and Patient Registration and assignment of patient study number. The physician will discuss the results of the Oncotype DX® assay with the patient once the result is available and upon receipt of the pre-test questionnaire. The physician will complete a follow-up questionnaire (to document recommended adjuvant systemic therapies post Oncotype DX®) after the result of the Oncotype DX® assay is known.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 18-79 years old * Operative Primary Breast Cancer * Node + (N1-3: micrometastasis) * ER + and HER 2- * Candidate for adjuvant chemotherapy in addition to hormonal therapy
Key inclusion criteria (8 listed)
- Operable breast cancer with the primary tumour (pT1-3)
- Pathological involvement (microscopic) of 1-3 lymph nodes. No minimum number of total lymph nodes need be resected. Extra-nodal extension of nodal deposit is allowed.
- Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines
- Patient's tumor must undergo central review at GHI and there must be adequate material for the Oncotype DX® assay.
- Patient's tumor must contain estrogen receptors (ER+).
Key exclusion criteria (9 listed)
- Patients have ER negative tumors (ER-) by local or central BCCA assessment
- Patients have HER2 positive tumors by local or central BCCA assessment
- Patients have four or more lymph node positive disease.
- Lymph node involvement by isolated tumor cells or cells by IHC only (less than 200 cells and/or ≤0.2 mm)
- Patients have known metastatic breast cancer.
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 |
|---|---|---|
| Oncotype DXThe Oncotype DX® assay is a multi-gene reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test that analyzes the expression of 21 genes, and quantifies the 10 year distant breast cancer recurrence risk in patients with stage I and II, lymph node negative, estrogen receptor positive disease who plan to be treated with tamoxifen for 5 years. | Other | – |
Primary outcome
Oncotype DX® assay affect on physician's treatment recommendations assessed by questionnaire
Time frame: 1 Month
The Oncotype DX® assay affect on physician's treatment recommendations pre and post Oncotype DX® Recurrence Score® result.
1 secondary outcome
Assessing Costs differences to the Publicly funded Health Care System
Time frame: Data will be analyzed within 8 weeks of enrollment completion and presented within 9 months of study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Results publication: PubMed 23611660Davidson JA, Cromwell I, Ellard SL, Lohrisch C, Gelmon KA, Shenkier T, Villa D, Lim H, Sun S, Taylor S, Taylor M, Czerkawski B, Hayes M, Ionescu DN, Yoshizawa C, Chao C, Peacock S, Chia SK. A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score(R) assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer. 2013 Jul;49(11):2469-75. doi: 10.1016/j.ejca.2013.03.009. Epub 2013 Apr 20.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by British Columbia Cancer Agency 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Chia, MD (604-877-6000, schia@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncotype DX® assay affect on physician's treatment recommendations assessed by questionnaire (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627703, which also lists 1 linked publication.
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 20 Jul 2016.