Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake
NCT ID: NCT02517593
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
151 participants
INTERVENTIONAL
2016-03-31
2019-12-01
Brief Summary
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Detailed Description
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At the time of the breast cancer prevention consultation, women will be offered participation in this study by a clinical trials nurse and informed written consent will be obtained. For consenting patients, a single 7 to 10 ml blood sample will be taken and couriered to the MAYO clinic for sample analysis and several surveys will be administered. One of the surveys will assess the participants understanding and intention to take or not take breast cancer preventing medications. The decision to take or not take a breast cancer preventing medication will be deferred until a subsequent follow up visit.
On the second visit, the PRS test results will be reviewed with the patient and a recommendation regarding preventive medications will be made. The PRS score will risk stratify patients into one of three lifetime risk categories of developing breast cancer (low risk (\<15 % lifetime risk), above average risk (15 to \<40% risk) and high risk (\>40%)). Participants will then answer a second survey in which their understanding of their breast cancer risk and intention to take breast cancer preventing medications will be assessed.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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PRS
Providing polygenic risk score (PRS)
Polygenic Risk Score
A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 77 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (\<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (\>40%).
Interventions
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Polygenic Risk Score
A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 77 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (\<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (\>40%).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Women with either of the following:
A. a NCI-BCRAT 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force (32); or B. Women with a IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥5%
3. Able to participate in all aspects of the study
4. Understand and signed the study informed consent
Exclusion Criteria
2. Women with known BRCA1 and BRCA2 mutations
3. Women with known contra-indications to Tamoxifen, raloxifene or exemestane
4. Unable to give informed consent
5. Prior history of invasive breast cancer or ductal carcinoma in situ
6. At risk due to prior radiation therapy to the chest
35 Years
75 Years
FEMALE
Yes
Sponsors
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CancerCare Manitoba
OTHER
Mayo Clinic
OTHER
Responsible Party
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Sandhya Pruthi, M.D.
Principal Investigator
Principal Investigators
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Sandhya Pruthi, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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CCM-003
Identifier Type: OTHER
Identifier Source: secondary_id
15-006204
Identifier Type: -
Identifier Source: org_study_id