The FDA Approves AI Tools for Breast Cancer Risk Prediction

In recent discussions, Senior Medical Analyst Dr. Mark Siegel explores the potential future risks associated with breast cancer and the advancements in artificial intelligence that may help predict increased health risks as cannabis use grows among older users.

A study from Northwestern University, Illinois, suggests that Duavee, a medication from Pfizer intended for menopausal symptoms, could also act as a preventive measure against breast cancer. This research highlights that Duavee significantly slows the growth of breast tissue cells, which is a critical factor in cancer progression.

The phase 2 clinical trial involved 141 postmenopausal women diagnosed with ductal carcinoma in situ (DCIS), a type of breast cancer. DCIS affects over 60,000 women in the U.S. annually and can sometimes lead to more invasive cancer diagnoses.

The participants were divided into two groups: one received Duavee, while the other was given a placebo, both taken for a month before surgery.

Duavee combines conjugated estrogen with bazedoxifene (CE/BZA), a therapy designed to minimize the side effects commonly associated with hormone treatments. Dr. Swati Kulkarni, leading the breast surgery department at Northwestern University Feinberg School, emphasized that CE/BZA effectively slows cell proliferation in the ducts of DCIS, showing more pronounced effects than the placebo.

Interestingly, both groups reported similar quality of life, but those on CE/BZA experienced fewer hot flashes, as the drug is already FDA approved for that purpose.

“What excites me most is that medications designed to help women feel better during menopause can also reduce the risk of invasive breast cancer,” Dr. Kulkarni shared during her presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

While the findings are promising, they remain preliminary, as they have not yet been reviewed or published in medical journals.

Dr. Kulkarni noted that particularly women with high-risk factors for breast cancer, such as those with high-risk lesions, could benefit from this treatment. However, they are typically advised against standard hormonal therapy and have limited options for managing menopause symptoms.

Research Considerations

While researchers are encouraged by these early observations, they acknowledge that further studies are necessary before considering CE/BZA for breast cancer prevention. “Our findings suggest potential, but we need larger studies over several years to draw definitive conclusions,” Dr. Kulkarni added.

Dr. Sheryal Kavraj, a breast medicine chief at Roswell Park Comprehensive Cancer Center, commented on the findings despite not being involved in the study. She described the research as intriguing yet preliminary and highlighted the need for more robust studies to establish the effectiveness of CE/BZA in reducing cancer risk.

“It’s intriguing, but this study is very preliminary,” Dr. Kavraj stated.

She also noted that the study focused on reducing a specific protein and did not directly link CE/BZA to reduced recurrence rates of breast cancer. Yet, the therapy did not affect patients’ quality of life negatively, and there were improvements in symptoms like hot flashes. If proven effective for breast cancer prevention, CE/BZA might have fewer side effects compared to existing medications.

Dr. Kulkarni pointed out that while this treatment isn’t for existing invasive breast cancer or DCIS, it provides an option for women looking to manage menopause symptoms while addressing breast cancer risks.