GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance

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 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 with at least one of the following:
    • 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; or
    • IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥ 8%;
    • History of atypical ductal hyperplasia or atypical lobular hyperplasia with a BCRAT ≥ 3% or IBIS ≥ 8%;
    • History of  lobular carcinoma in situ with a BCRAT ≥ 3% or IBIS ≥ 8%.

OR

  • Women ≥ 18 years old or ≤ 75 years old with a:
    • BRCA 1 or 2  mutation;
    • CHEK 2;
    • PALB 2;
    • ATM; or other hereditary breast mutation carrier per investigator; 

AND

  • Able to participate in all aspects of the study.
  • Understand and sign 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 < 8% for the 10 year risk.
  • Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole.
  • Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole for ≥ 6 months.
  • Unable to give informed consent.
  • Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers.
  • Prior bilateral  prophylactic mastectomy.
  • Women who are currently pregnant.

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

Jacksonville, Fla.

Mayo Clinic principal investigator

Lauren Cornell, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Sandhya Pruthi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Barbara Pockaj, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20468925

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