March 12, 2021
Researchers at The University of Kansas Cancer Center have received a $4.2 million, five-year grant from the National Cancer Institute to study the effects of bazedoxifene and low-dose conjugated estrogen in women who are at increased risk for developing breast cancer and are experiencing menopausal symptoms. Duavee®, a medication containing both drugs, is FDA-approved for hot-flash relief and prevention of osteoporosis. Now, researchers are studying it for its potential to reduce the risk of breast cancer.
According to Carol Fabian, MD, principal investigator and founder of KU Cancer Center’s Breast Cancer Prevention and Survivorship Research Center, women at increased risk for breast cancer may take anti-hormonal drugs such as tamoxifen to reduce their chances of developing the disease, but only about 4% of eligible women agree to do so.
“Although tamoxifen can reduce risk of breast cancer risk by half, it commonly initiates or worsens menopausal symptoms such as hot flashes and night sweats”. Dr. Fabian said. “As a result, a large majority of women choose to forgo therapy.”
To identify a new preventive therapy that will reduce the risk of breast cancer and alleviate, not induce, menopausal symptoms, Dr. Fabian and her team are launching a clinical trial to build on the results of a pilot study that wrapped up in 2020. The pilot study found that women who took bazedoxifene and conjugated estrogen (Duavee®) for six months had a reduction in mammographic breast density and other risk biomarkers for breast cancer, including indicators of growth in breast tissue. Moreover, participants reported an improvement in hot flashes. Participants reported a median hot flash score of 15 at the beginning of treatment and zero at six months.
The clinical trial will begin early summer 2021, and Dr. Fabian and her team plan to enroll 120 women ages 45 to 60 with hot flashes and who are at increased risk for breast cancer. The University of Kansas Cancer Center is leading the multi-site clinical trial. Participating sites include Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Dana Farber Cancer Institute, City of Hope Comprehensive Cancer Center and University of California-San Francisco Helen Diller Family Comprehensive Cancer Center.
“We were impressed by the results of the pilot study, and with the National Cancer Institute’s support, we have the opportunity to study this in a larger patient population,” Dr. Fabian said. “Our hope is to identify a prevention option that is effective in reducing breast cancer risk and improves rather than worsens a woman’s quality of life.”