CompletedPhase 1/2

Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake

United States, Canada151 participantsStarted 2016-03

Plain-language summary

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

Who can participate

Age range35 Years – 75 Years

SexFEMALE

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Inclusion criteria

✓. Women \> 35 years old and \< 75 years old
✓. Women with either of the following:
✓. 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

What they're measuring

Patient self-reported intention to take a breast cancer preventing medication

Timeframe: up to 6 months after initial consultation

Trial details

NCT IDNCT02517593

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-01

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