A drug already approved by the FDA to treat menopause symptoms may also help to prevent invasive breast cancer, according to recent findings from a clinical trial led by Northwestern Medicine. The research was presented at the 2025 ASCO Annual Meeting (Abstract 512).
Study Details
The multicenter, randomized phase II trial was conducted between September 2017 and August 2024. The trial included 141 postmenopausal women diagnosed with ductal carcinoma in situ, which is considered a precursor to invasive breast cancer and is diagnosed in roughly 60,000 women each year in the United States. Participants across 10 sites nationwide were randomly assigned to receive a combination of conjugated estrogens and bazedoxifene or a placebo for about 4 weeks between diagnosis and scheduled breast surgery.
Key Findings
Researchers found that the drug significantly reduced cell growth in breast tissue, a key marker of cancer progression. This combination treatment was well tolerated by trial participants.
“What excites me most is that a medication designed to help women feel better during menopause may also reduce their risk of invasive breast cancer,” said Swati Kulkarni, MD, a Northwestern Medicine breast surgeon and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
According to Dr. Kulkarni, the women most likely to benefit from the combination of conjugated estrogens and bazedoxifene are those at an elevated risk for breast cancer due to a personal history of high-risk lesions such as atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or prior ductal carcinoma in situ, and who are also experiencing menopausal symptoms. These women are typically advised against standard hormone therapies, leaving them with few menopausal treatment options.
Although a larger study with longer-term follow-up is needed before this combination treatment can be considered for breast cancer prevention, Dr. Kulkarni said she was encouraged by the early results, particularly because the drug is already FDA-approved and widely available.
Disclosure: This study was funded by the U.S. National Institutes of health. For full disclosures of the study authors, visit coi.asco.org.
