A Study to See if Genetic Risk Estimation of Breast Cancer Influences the Use of Preventive Medication

Overview

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:

  1. Women > 35 years old and < 75 years old
  2. Women with either of the following:
    1. 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
    2. 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:

  1. 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
  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

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sandhya Pruthi, M.D.

Closed for enrollment

Contact information:

Department of Medicine – Clinical Research Office

(507) 266-1944

RSTDOMCRO@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20273189

Mayo Clinic Footer