Jose Pablo Leone, MD

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 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.

Progress Thus Far

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.

What’s next

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.