The Who, What, Where, When and Sometimes, Why.

Emerging Areas in Risk Reduction and Estimating Risk

Breast cancer risk reduction and risk assessment are active areas of research.

Some studies are looking at ways to reduce risk (such as new risk-lowering drugs) in women at higher than average risk of breast cancer.

Other studies are focused on new and better ways of knowing which women and men are at higher risk.

Risk-lowering drugs

Some drugs used to treat breast cancer are under study for their use as risk-lowering drugs for women at higher than average risk.

New risk-lowering drugs are also being developed.

Learn about tamoxifen and raloxifene (FDA-approved drugs for lowering the risk of breast cancer).

Aromatase inhibitors

Aromatase inhibitors are hormone therapy drugs used to treat estrogen receptor-positive breast cancer in postmenopausal women.

Exemestane (Aromasin) and anastrozole (Arimidex)

Findings from randomized controlled trials of postmenopausal women at high risk of breast cancer have shown the aromatase inhibitors exemestane and anastrozole may reduce the risk of breast cancer by about half [252-253].

Unlike tamoxifen and raloxifene (currently FDA-approved for risk reduction), exemestane and anastrozole don’t appear to increase the risk of blood clots [252-253]. However, they can cause menopausal symptoms, a loss of bone density and other side effects [252-253,340-343].

The American Society for Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN) and the U.S. Preventive Services Task Force list exemestane and anastrozole as risk-lowering drug options for postmenopausal women at higher risk of breast cancer. 

However, exemestane and anastrozole don’t have FDA-approval for use in the risk reduction setting. They are only FDA-approved for use in breast cancer treatment.

Learn about aromatase inhibitors (including exemestane and anastrozole) and breast cancer treatment.

Learn more about the side effects of aromatase inhibitors.

Other aromatase inhibitors

The aromatase inhibitor drug letrozole (Femara) is also being studied to see whether it may lower risk in postmenopausal women at high risk of breast cancer.

Learn about aromatase inhibitors and breast cancer treatment.

Lasofoxifene

Lasofoxifene is an osteoporosis drug similar to tamoxifen and raloxifene.

Early findings suggest lasofoxifene may reduce the risk of estrogen receptor-positive breast cancer in women at risk for osteoporosis [347-349]. More data are needed to confirm these findings.

Clinical trials of risk-lowering drugs

If you are at higher than average risk of breast cancer and considering joining a clinical trial of risk-lowering drugs, we encourage you to discuss the potential risks and benefits with your health care provider.

Susan G. Komen® Breast Cancer Clinical Trial Information Helpline
If you or a loved one needs information or resources about clinical trials, call our Clinical Trial Information Helpline at 1-877 GO KOMEN (1-877- 465- 6636) or email clinicaltrialinfo@komen.org.

BreastCancerTrials.org in collaboration with Susan G. Komen® offers a custom matching service to help clinical trials on risk reduction.

Learn more about clinical trials.

Using breast cells to assess risk

Methods to assess breast cancer risk currently under study include [350]:

These procedures remove cells from the breast.

A pathologist looks at the cells under a microscope. Abnormal (atypical) cells may be linked to an increased risk of breast cancer.

The procedures differ in how the cells are removed from the breast. 

Ductal lavage

Ductal lavage uses a small tube to flush out fluid from the nipple. This fluid contains breast cells.

This procedure causes some discomfort.

Ductal lavage has not yet been shown to be effective for breast cancer risk assessment [179,350]. It’s not recommended for use outside of a clinical trial [179].

More research is needed to learn how to use the findings from ductal lavage. 

Nipple aspiration (nipple aspirate fluid cytology)

Nipple aspiration (such as the HALO test) uses a breast pump (and sometimes massage) to remove fluid from the nipple.

Nipple aspiration has not yet been shown to be effective for breast cancer risk assessment [179,350]. It’s not recommended for use outside of a clinical trial [179].

More research is needed to learn how to use the findings from nipple aspiration.

Random periareolar fine needle aspiration (RPFNA)

RPFNA uses a thin needle to remove cells from about 10 areas near the areola.

This procedure is more invasive and causes more discomfort than ductal lavage, nipple aspiration or fine needle aspiration done for diagnosis.

RPFNA is not recommended for use outside of a clinical trial [179].

Ductal lavage, nipple aspiration or RPFNA and risk assessment

Ductal lavage, nipple aspiration and RPFNA are not recommended for use outside of a clinical trial [179].

The findings from these tests should not impact a woman’s decision to take risk-lowering drugs (tamoxifen or raloxifene), have preventive surgery or join a risk reduction clinical trial. They also should not be used to assess risk for breast cancer screening recommendations.

More research is needed to learn how to use the findings from these tests.

Breast cancer risk assessment is not breast cancer screening

Tests such as ductal lavage, nipple aspiration and RPFNA are under study for risk assessment. Risk assessment is not breast cancer screening (tests used to find cancer early).

The U.S. Food and Drug Administration (FDA) states tests such as nipple aspiration should not be used in breast cancer screening or diagnosis [351]. In 2013, the FDA issued an alert warning people these tests should never be used as substitutes for mammography or other breast cancer screening tools [351]. 

 

 Our commitment to research

At Susan G. Komen®, we are committed to saving lives by meeting the most critical needs in our communities and investing in breakthrough research to prevent and cure breast cancer. Our Research Program is an essential driving force for achieving this mission. 

Since our inception in 1982, Komen has provided funding to support research grants that have greatly expanded our knowledge of breast cancer and helped us understand that breast cancer is not just a single disease but many diseases, unique to each individual. 

Going forward, our commitment to research will contribute significantly to our ability to achieve our Bold Goal of reducing the current number of breast cancer deaths in the U.S. by 50 percent.

To date, Komen has provided more than $1 billion to researchers in 47 states, the District of Columbia and 24 countries to support research that has resulted in a better understanding of breast cancer; earlier detection; personalized, less invasive treatments for what was once a “one-treatment-fits-all” disease; and improvements in both quality of life and survival rates.

Learn more about our continuing investment in research and the exciting research that we are funding, because nothing would make us happier than ending breast cancer forever.

 

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