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Carol J. Fabian, MD
Professor of Internal Medicine
Director, Breast Cancer Prevention and Survivorship Centers
Morris Family Endowed Chair in Cancer Prevention
University of Kansas Medical Center
Kansas City, Kansas
Seeking to develop strategies to prevent breast cancer in moderate to high risk women and to improve health and quality of life for breast cancer survivors.
A pilot clinical trial is ongoing to test a medicine used to treat hot flashes as a potential breast cancer preventive.
If study results are positive, the use of an approved drug may be expanded as an alternative or supplement to standard chemoprevention therapies.
Approximately 75% of women undergoing menopause transition will have vasomotor symptoms (e.g., hot flashes and night sweats) which impact their quality of life. Hormone replacement therapy (HRT) is the most effective way to reduce vasomotor symptoms, but there is concern that it might increase risk for development of breast cancer. Dr Fabian is conducting a study to see if a drug used to prevent hot flashes may be a safe alternative to HRT therapy in women at risk of breast cancer.
Full Research Summary
FDA-approved drugs for breast cancer prevention called selective estrogen receptor modulators (SERMs; such as tamoxifen and raloxifene) often induce or worsen hot flashes and night sweats in women experiencing menopause, so many women are unwilling to use them.
Duavee® (a combination of the SERM bazodoxifene plus conjugated estrogens) is FDA approved for relief of hot flashes and prevention of osteoporosis, unless a woman has breast or other estrogen-dependent cancer. Although no restrictions exist for Duavee® in women who are only at risk for development of breast cancer, physicians are reluctant to prescribe it in this situation.
Laboratory studies suggest that Duavee® does not increase the cause proliferation (rapid growth) of breast cells (which may increase risk for developing breast cancer) but may actually slow down breast cell growth. Dr. Fabian and her team recently completed a clinical pilot study and confirmed that Duavee® does not increase proliferation in women who are at moderate risk for breast cancer, and in fact decreases mammographic breast density (a known risk factor for breast cancer development).
This supports progression to a randomized, placebo-controlled clinical trial to demonstrate the potential of Duavee® for breast cancer prevention. A successful trial would allow greater use of a proven treatment for hot flashes in this population. This therapy may be useful as a breast cancer prevention agent that does not cause (but actually prevents) the symptoms that currently limit the use of such therapies by women at high risk for breast cancer.
Carol Fabian received her MD, internal medicine and oncology training from the University of Kansas School of Medicine in Kansas City, Kansas. Dr. Fabian joined the faculty at the University of Kansas Medical Center in 1977 and currently holds the rank of Professor. She serves as the Director of the Breast Cancer Prevention and Survivorship Centers. These centers are heavily involved in translational research in addition to providing clinical services. She leads the Cancer Prevention Research Program within the University of Kansas Cancer Center and holds the Morris Family Endowed Chair in Cancer Prevention.
Dr. Fabian pioneered the use of random periareolar fine needle aspiration to acquire breast epithelial cells for refinement of breast cancer risk assessment. The technique is also used for evaluation of biomarkers to monitor response in early phase breast cancer prevention clinical trials: 1) weight loss in combination with omega-3 fatty acid supplementation; 2) a flaxseed lignin derivative; and 3) an aromatase inhibitor in postmenopausal women taking hormone replacement. She is also involved in clinical studies to promote health and quality of life for breast cancer survivors and serves as a Co-Chair for the Cancer Survivorship Committee of SWOG.