Titles and Affiliations
Assistant Professor, Harvard Medical School
Director of the Program for Breast Cancer in Men, Dana-Farber Cancer Institute
Conquer Cancer, the ASCO Foundation
Research area
Investigating endocrine therapy treatments for men with breast cancer.
Impact
Breast cancer mortality and survival rates have significantly improved for women in recent years. However, there has been no significant improvement in survival for male breast cancer in the past three decades. The treatment for male breast cancer, which is almost always estrogen receptor (ER)-positive, remains a challenge because there is very little data on the optimal endocrine therapy for men. Dr. Leone’s Conquer Cancer research, supported by BCRF, is focused on launching a multicenter phase II study for men with stage I, II, and III ER-/progesterone (PR)-positive HER2-negative breast cancer (ETHAN study).
Progress Thus Far
In the first phase of the study, the team will assess how well different antiestrogen treatments – tamoxifen, aromatase inhibitors (AIs), and an AI combined with gonadal suppression – reduce tumor cell growth in men with breast cancer. These therapies are designed to slow or stop the growth of breast cancers that rely on estrogen. In the second phase, the team will test whether adding the CDK4/6 inhibitor abemaciclib (Verzenio®), a drug that blocks signals promoting cancer cell division, to endocrine therapy improves response to neoadjuvant (pre-surgical) treatment compared to endocrine therapy alone. The trial is enrolling patients at seven participating locations, and Dr. Leone is working to make the study available at other locations this year.
What’s next
The research team will continue enrolling patients to the trial to meet the target of 60 patients and analyze samples already collected from patients enrolled. Similar studies have shown these combination therapies work well in women, and Dr. Leone’s research will provide the evidence needed for evaluating different endocrine therapy options for men to help guide optimum treatment decisions for this disease.
Biography
José Pablo Leone, MD is a medical oncologist and clinical investigator in the Breast Oncology Center at Dana-Farber Cancer Institute (DFCI). He serves as the Director of the Program for Breast Cancer in Men. His research focuses on brain metastases, male breast cancer and research with large databases. He received his MD from Universidad del Salvador, Argentina. He completed his residency in Internal Medicine at the University of Miami Jackson Memorial Hospital and went on to complete fellowships in Hematology and Medical Oncology at the University of Pittsburgh Medical Center. He was faculty at University of Iowa Hospitals and Clinics from 2014 to 2017. In 2017, he joined the staff of Brigham and Women’s Hospital and DFCI, where he is Assistant Professor of Medicine at Harvard Medical School.
