Early research on a drug to prevent breast cancer

Expert Guidelines

The National Comprehensive Cancer Network (NCCN) provides breast cancer risk management guidelines for people with BRCA1 and BRCA2 mutations. We recommend that you speak with a genetics expert who can look at your personal and family history of cancer and can help you to determine the best risk management plan. 

Screening for women:

• Learn to be aware of changes in breasts beginning at age 18.
• Clinical breast exam every 6-12 months beginning at age 25.
• Annual breast MRI with contrast (or mammogram if MRI is unavailable) beginning at age 25 and continuing until age 75.
• Annual mammogram at age 30 until age 75 (consider 3D mammography if available).
• Screening after age 75 should be considered on an individual basis.

Risk reduction for women:

• Women should have a discussion with their doctors about of the advantages and disadvantages of risk-reducing mastectomy.
  • Research has shown that risk-reducing mastectomy can lower the risk for breast cancer in high risk women by about 90%. Despite this, mastectomy has not been shown to help high risk women live longer.
  • Even after mastectomies, some breast tissue-and therefore some breast cancer risk remains. 
• Women should have a conversation with their doctor about the possible benefits of tamoxifen or other estrogen-blocking drugs to reduce breast cancer risk in women with BRCA2 mutations. Research on the benefit of these drugs to reduce breast cancer risk in women with BRCA1 mutations has been mixed.

Risk management in men:

• Breast self-exam training and education beginning at age 35.
• Clinical breast exam every 12 months beginning at age 35.
• In men with enlarged breasts, (gynecomastia) consider annual mammogram in men with gynecomastia beginning at age 50 or 10 years younger then the earliest case of male breast cancer in the family (whichever comes first). 

Questions To Ask Your Health Care Provider

• I am a BRCA1 mutation carrier. What can I do to lower my breast cancer risk?
• I am a BRCA mutation carrier who has not had cancer. Are there clinical trials looking at new ways to prevent cancer, and do I qualify for them?
• Are there currently drugs available to lower the risk of breast cancer in BRCA mutation carriers?

Open Clinical Trials

The following are breast cancer screening or prevention studies enrolling people at high risk for breast cancer.   

• NCT04711109: Denosumab for Preventing Breast Cancer in Women with a BRCA1 Inherited Mutation (BRCA-P). This study will test the effectiveness of a drug (denosumab) on preventing the development of breast cancer in women with an inherited BRCA1 mutation.
• NCT04067726: Denosumab and Mammographic Density in Premenopausal Women With Dense Breasts (TRIDENT). This study is looking at the drug denosumab to learn if it can reduce breast density in high-risk premenopausal women who have dense breasts. 
• The Risk Factor Analysis of Hereditary Breast and Ovarian Cancer In Women  with BRCA1, BRCA2 or PALB2 Mutations.  This study seeks to improve researchers’ understanding of how hormonal, reproductive and lifestyle factors may be associated with cancer in high-risk people.
• NCT02620852: Women Informed to Screen Depending on Measures of Risk (WISDOM) study.  The goal of this study is to determine if breast cancer screening can be made better by personalizing each woman’s mammogram schedule, compared to the current one-size-fits-all, annual approach.

Additional risk-management clinical trials for people at high risk for breast cancer may be found here.