MDACC Study No:2007-0125 ( NCT No: NCT00524277)
Title:Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence
Principal Investigator:Elizabeth A. Mittendorf
Treatment Agent:GM-CSF; Peptide Vaccine
Study Status:Closed
Study Description:The goal of this clinical research study is to find out whether GP2 or AE37,
given as a vaccine combined with GM-CSF, or GM-CSF alone can help keep
node-positive or high-risk node-negative breast cancer from coming back. The
safety of the treatment and its ability to help boost your body's immune system
against the cancer will also be studied.
Hide details for General InformationGeneral Information

Disease Group:Breast
Phase of Study:Phase II
Treatment Agents:GM-CSF
Peptide Vaccine
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:N/A
Supported By:Antigen Express,
Return Visit:Once monthly for 6 months
Home Care:N/A

Hide details for Study Contact InformationStudy Contact Information

Physician Name:Elizabeth A. Mittendorf
Dept:Surgical Oncology
For Clinical Trial Enrollment:713-792-6940
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults