Dana-Farber Cancer Institute Boston, Massachusetts
Assistant Professor, Harvard Medical School Director of the Program for Breast Cancer in Men, Dana-Farber Cancer Institute
Conquer Cancer, the ASCO Foundation
Investigating endocrine therapy treatments for men with breast cancer.
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 and his team are conducting a multicenter phase II study for men with stage I, II, and III ER-/progesterone (PR)-positive HER2-negative breast cancer.
The trial began enrolling patients at four participating locations, and Dr. Leone is working to make the study available at other locations this year. It is expected that about 60 men will take part in this research study.
In the first phase of the study, the team will evaluate the effectiveness of an anti-estrogen medication called tamoxifen, aromatase inhibitors (AIs, which work by decreasing the amount of estrogen the body makes), and an AI in combination with gonadal suppression on tumor proliferation. These treatments can slow or stop the growth of breast tumors that need estrogen to grow.
In the second phase, the team will evaluate whether adding the CDK4/6 inhibitor abemaciclib (Verzenio®), a drug that blocks cell division and tumor growth to either tamoxifen or an AI plus gonadal suppression increases the efficacy of the treatment before surgical intervention. The team will also quantify the degree of increased tumor cell death induced by endocrine therapy with and without the addition of abemaciclib. Similar studies have shown these combination therapies work well in women. Dr. Leone’s Conquer Cancer research, supported by BCRF, will provide evidence for the efficacy of different endocrine therapy options for men.
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.
2023
The Roslyn and Leslie Goldstein Award
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