Andrea De Censi, MD

Testing various strategies to improve breast cancer chemoprevention.

Impact

Women with high-risk of breast cancer include those with 1) precancerous breast lesions or abnormal overgrowth known as hyperplasia; 2) older age, dense breast and family history of breast cancer; 3) genetic predisposition for genes like BRCA2, PALB2 or other genes; 4) chest wall irradiation prior to age 30 for cancer. These high-risk women may benefit from preventive therapy with anti-estrogen/hormonal medicines (like tamoxifen and exemestane) to decrease risk of future invasive breast cancer. However, the uptake of this intervention has been low due to concerns over side effects like musculoskeletal pain, hot flashes and sexual disturbances. To overcome these barriers to usage, Dr. De Censi and team have conducted a randomized study in high-risk women post-surgery or in those with localized disease, which showed that low dose anti-hormonal therapy tamoxifen (babytam) given for shorter time decreased risk of subsequent breast cancer by 50 percent versus placebo without increasing side effects. Another strategy Dr. De Censi’s team has studied in the pre-surgery setting in postmenopausal women with breast cancer is comparing three different schedules of exemestane: once a week, every-other day, or the standard dose of once a day. The study found that the every other day schedule worked equally well as standard dose in reducing blood estrogen levels. Next, with BCRF funding, Dr. De Censi will study if further improvements to quality of life can be made by comparing every other day of tamoxifen to every other day exemestane. This study will inform a larger study aimed at defining the safest and most effective preventive medication.

What’s next

This study is anticipated to open in 2023 and enroll over 2 years. It will open across seven clinical sites globally (Galliera Breast Unit in Genoa, Italy; Dana Farber Cancer Institute in Boston, Massachusetts; European Institute of Oncology in Milan, Italy; Centro de Patologia de la Marma in Madrid, Spain; Karolinska Institute in Stockholm, Sweden; Uekeland University of Bergen, Norway and University Hospital of Parma in Parma, Italy). Dr. De Censi anticipates that the results of the study will inform new approaches to breast cancer prevention that are better tolerated and have potential for broader uptake and impact.