Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID: NCT02517593
Run by: Mayo Clinic
People needed: 151
Starts: 2016-03-01
Expected to finish: 2019-12-01
Last updated by the study team: 2020-12-30

Who can join

Age: 35 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Women > 35 years old and < 75 years old
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%
Able to participate in all aspects of the study
Understand and signed the study informed consent

You may not qualify if…

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

Where it is running

Mayo Clinic in Rochester — Rochester, Minnesota, United States
CancerCare Manitoba — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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