A Study to See if Genetic Risk Estimation of Breast Cancer Influences the Use of Preventive Medication
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006204
NCT ID: NCT02517593
Sponsor Protocol Number: 15-006204
About this study
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Women > 35 years old and < 75 years old
- Women with either of the following:
- 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 or
- Women with a IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥5%
- Able to participate in all aspects of the study
- Understand and signed the study informed consent
Exclusion Criteria:
- Women whose BCRAT falls below the threshold (<3 % 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is <5% for the 10 year risk
- Women with known BRCA1 and BRCA2 mutations
- Women with known contra-indications to Tamoxifen, raloxifene or exemestane
- Unable to give informed consent
- Prior history of invasive breast cancer or ductal carcinoma in situ
- At risk due to prior radiation therapy to the chest
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Sandhya Pruthi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available