Potential of Duavee in Preventing Invasive Breast Cancer: Clinical Trial Highlights

Research from a multi-center phase 2 clinical trial has revealed encouraging findings on Duavee, a medication already approved by the FDA for managing menopause symptoms, showing it may also play a role in preventing invasive breast cancer. Led by Northwestern Medicine, the study involved 141 postmenopausal women diagnosed with ductal carcinoma in situ (DCIS), a non-invasive condition that can precede invasive breast cancer and affects thousands of women annually in the U.S.

Participants across ten different sites were randomized to receive either Duavee—a combination of conjugated estrogens and bazedoxifene—or a placebo for approximately four weeks prior to their scheduled breast surgery. The trial's results demonstrated that Duavee significantly decreased cell proliferation in breast tissue, which is a critical marker of cancer progression. Notably, the medication was well tolerated, with participants experiencing minimal side effects, unlike other preventive drugs that often cause adverse effects leading to discontinuation.

Dr. Swati Kulkarni, the lead researcher and a breast surgery expert at Northwestern University Feinberg School of Medicine, expressed optimism about the findings. She highlighted that a drug originally designed to alleviate menopausal discomfort might also reduce the risk of invasive breast cancer. The study suggests that women at higher risk—due to conditions like atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or previous DCIS—who also suffer from menopausal symptoms could particularly benefit from Duavee. This is especially relevant for women who cannot use traditional hormone therapies.

While these early outcomes are promising, Dr. Kulkarni emphasized that a larger, longer-term study is necessary to confirm Duavee’s potential as a preventive treatment for breast cancer. Nonetheless, the fact that the drug is already FDA approved and widely accessible makes it a compelling candidate for future research.

The detailed findings will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The study underscores the possibility of repurposing existing medications to provide new preventive options against breast cancer, a disease that remains one of the leading causes of cancer-related mortality among women.

Source: https://medicalxpress.com/news/2025-05-menopause-drug-duavee-invasive-breast.html