A Phase I Study of HER2/neu DNA Immunization for Patients with Metastatic or High-Risk Breast Cancer

Protocol
04-101
Full Title
Xenogeneic HER2/NEU DNA Immunization for Patients with Metastatic or High Risk Breast Cancer: a Phase I Study to Assess Safety and Immunogenicity
Phase
I
Purpose

Scientists are developing immunological therapies that trigger a response by a patient’s immune system against the cancer. The purpose of this study is to determine the highest dose of an immunotherapy called HER2/neu immunization that can be given safely, and to see if this preparation can stimulate an immune response in women with breast cancer that has metastasized (spread) or has a high risk of metastasizing.

Antigens are targets for immune cells. If an immune cell recognizes an antigen on a tumor cell, it may help to trigger a reaction against the tumor. The immunization prepared for this clinical trial targets an antigen called the HER2 protein, which is over-produced by some breast cancer cells.

The injection used in this study is a piece of DNA (genetic material) made in bacteria which contain the gene for rat HER2.

Eligibility

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

  • Patients must be women with metastatic breast cancer or stage III breast cancer that has a high risk of metastasizing. Patients’ breast tumors must overexpress the HER2/neu protein.
  • At least 4 weeks must have passed since completion of prior surgery, chemotherapy, radiation therapy, or antibody therapy (such as trastuzumab), and patients must have recovered from any side effects.
  • Patients must be age 18 or older.

For more information and to see if you are eligible for this study, please contact Dr. Teresa Gilewski at 646-888-5451.

Disease(s)
Breast Cancer
Locations
Related Diseases