Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

This is a minimal risk prospective multisite study with a single arm incorporating the PRS into a standard breast cancer risk reduction consultation, followed by annual surveys over 10 years to determine if and how the availability of the PRS influenced patient decisions regarding preventive medicine and medication compliance. Because women know beforehand that the PRS is pending, study participants will be advised that a final decision to take preventive medicine must be deferred until after the PRS results are made available. Nevertheless, a survey of understanding of risk and benefit and assessment of willingness to take preventive medicine will be done prior to receiving the PRS results and then another survey will be completed after receiving the PRS score.

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Eligibility Criteria

Inclusion Criteria:

Women > 35 years old and < 75 years old

Women with any 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. IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥8% 43 C. Biopsy proven atypical ductal hyperplasia or atypical lobular hyperplasia. D. History of lobular carcinoma in situ E. BRCA mutation carrier or other hereditary breast mutation carrier

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 <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
Unable to give informed consent
Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers
At high risk due to prior radiation therapy to the chest
Women who are pregnant or breastfeeding
Prior risk reducing or prophylactic mastectomy

Study is for people with:

Breast Cancer

Estimated Enrollment:

900

Study ID:

NCT04474834

Recruitment Status:

Enrolling by invitation

Sponsor:

Mayo Clinic

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There are 5 Locations for this study

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Mayo Clinic
Scottsdale Arizona, 85259, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Northwestern University
Evanston Illinois, 60208, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

900

Study ID:

NCT04474834

Recruitment Status:

Enrolling by invitation

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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