A Pilot Study of Single-Dose Ipilimumab and/or Cryoablation in Women with Early-Stage Breast Cancer Scheduled for Mastectomy

Protocol
11-202
Full Title
A Pilot Study of Pre-Operative, Single-Dose Ipilimumab and/or Cryoablation in Early Stage/Resectable Breast Cancer
Purpose

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.
Investigator
Heather L. McArthur
Heather L. McArthur - Physician Profile
Co-Investigators
Stephen B. Solomon, MD -- Chief, Interventional Radiology Service
Stephen B. Solomon - Physician Profile
Larry Norton, MD -- Deputy Physician-in-Chief for Breast Cancer Programs; Medical Director, Evelyn H. Lauder Breast Center; Norna S. Sarofim Chair in Clinical Oncology
Larry Norton - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have early-stage breast cancer measuring 1.5 cm or greater and be candidates for mastectomy.
  • Patients may not have any anticancer therapy within 4 weeks of receiving ipilimumab (if they are chosen to receive this drug).
  • Patients with autoimmune diseases (such as inflammatory bowel disease, lupus, or rheumatoid arthritis) may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Heather McArthur at 646-888-5071.

Disease(s)
Breast Cancer
Locations
ClinicalTrials.gov
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Clinical Trials

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