A drug known as Duavee, which is already approved by the FDA for treating menopause symptoms, may also play a role in preventing invasive breast cancer. This conclusion comes from a phase 2 clinical trial led by Northwestern Medicine.
Dr. Swati Kulkarni, who serves as the lead investigator and is a professor of breast surgery at Northwestern University Feinberg School of Medicine, will be presenting these findings on June 1 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Dr. Kulkarni is open to interviews surrounding this event.
The trial involved 141 postmenopausal women diagnosed with ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer that could potentially develop into invasive breast cancer. Approximately 60,000 cases are diagnosed annually in the United States.
Participants were randomized across ten sites nationwide to receive either Duavee — which combines conjugated estrogens and bazedoxifene — or a placebo for around four weeks before their scheduled breast surgery.
According to Kulkarni’s team, Duavee significantly reduced cell growth in breast tissue, an important indicator of cancer progression. Unlike other drugs aimed at preventing breast cancer that can cause severe side effects leading patients to avoid them, Duavee was well tolerated by those participating in the trial.
“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 Dr. Kulkarni, who also practices as a Northwestern Medicine breast surgeon and is affiliated with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
Kulkarni highlighted that women who might benefit most from Duavee include those at increased risk for breast cancer due to conditions such as atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), or previous DCIS diagnoses — particularly if they are experiencing menopausal symptoms. These women often cannot use standard hormone therapies and have limited treatment options for menopause symptoms; thus, Duavee could provide an effective alternative.
Although more extensive studies with longer follow-up periods are necessary before considering Duavee as a preventive measure against breast cancer, Dr. Kulkarni expressed optimism about these initial results because the drug is already FDA-approved and widely accessible.
Dr. Kulkarni remains available for media discussions regarding these clinical trial outcomes and their implications for preventing breast cancer alongside addressing broader issues faced by women during menopause.