Details

IRB Study Number 21-787

Status Recruiting

Location Cleveland Clinic Main Campus

Institutes Digestive Disease & Surgery Institute, Taussig Cancer Institute

Description

Description

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.

An additional aim is to determine if the addition of the PRS to the BCRAT or IBIS risk score will aid women in deciding whether or not to pursue supplemental breast cancer screening such as MRI, molecular breast imaging (MBI), or contrast-enhanced digital mammography (CEDM).

Another goal is to follow this cohort of women over 10 years to determine subsequent outcomes in regards to diagnoses of at-risk lesions or cancer and to obtain additional markers of increased breast cancer risk using DNA methylation to assess risk for breast cancer development.

Inclusion Criteria

Inclusion Criteria

  1. Women > 35 years old and < 75 years old with at least one 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; or

B. IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥8%

C. History atypical ductal hyperplasia or atypical lobular hyperplasia with a BCRAT ≥ 3% or IBIS ≥ 8%

D. History of lobular carcinoma in situ with a BCRAT ≥ 3% or IBIS ≥ 8%

OR

  1. 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

  1. Able to participate in all aspects of the study

  2. Understand and sign the study informed consent

Exclusion Criteria

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

  2. Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole

  3. Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole for ≥ 6 months

  4. Unable to give informed consent

  5. Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers

  6. Prior bilateral prophylactic mastectomy

  7. Women who are currently pregnant.