Combining cryoablation (using freezing temperatures to kill a tumor) and immunotherapy may train a patient’s immune system to fight cancer cells. In this study, researchers want to determine the safety of cryoablation and immunotherapy in women with early-stage breast who are scheduled to have a mastectomy. It is hoped that the cryoablation and immunotherapy given before the mastectomy will reduce the risk of cancer recurrence.
The immunotherapy being assessed in this study is the drug ipilimumab, which is FDA-approved for treating melanoma. Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that an antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune response that may help the body to destroy cancer cells. To help focus the response to the cancer, cryoablation is being used to break the cancer into fragments that can be more easily recognized by the immune system.
Women in this study will have one of three investigational therapies before their scheduled mastectomy:
- cryoablation only
- a single dose of ipilimumab only, OR
- cryoablation plus single-dose ipilimumab.