E.O. Ospedali Galliera
Director, Department of Medicine and Division of Medical Oncology
Scientific Advisor, Division of Cancer Prevention
European Institute of Oncology, Milan, Italy
Honorary Professor, Wolfson Institute of Population Science
Queen Mary University, London, UK
Testing various strategies to improve breast cancer chemoprevention.
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.
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.
Andrea De Censi, MD is the Director of the Department of Medicine since 2021 and Director of the Division of Medical Oncology, Galliera Hospital, Genoa, Italy since 2004. His research interests are focused on prevention of breast cancer. He has served as principal investigator in over 40 phase II and phase III cancer prevention and treatment clinical trials involving over 15,000 participants, all of which are not for profit trials supported by National or International Agencies, including the Italian Health Ministry, the Italian Association for Cancer Research, the League against Cancer, the US-NCI, the Susan Komen Foundation, the Berlucchi Foundation and the Breast Cancer Research Foundation.
Dr. De Censi is an internationally recognized expert in cancer chemoprevention having discovered that antihormone therapy like Tamoxifen can prevent breast cancer in women and defined optimal dosing for Tamoxifen and Exemestane. His seminal work in breast cancer chemoprevention led him and co-founders Umberto Veronesi and Alberto Costa to establish the first Clinical Unit of Cancer Chemoprevention in Italy in 1995. Dr. De Censi has contributed to major advances in breast cancer prevention research that are practiced in the clinic today.
Dr. De Censi has authored 276 peer-reviewed publications, mostly as first or senior author. He has served as a member of several Committees for Cancer Prevention for ASCO, AACR and ESMO. He has also mentored many young clinicians and scientists to develop this growing branch of medical oncology.
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