Status:
COMPLETED
Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2. PURPOSE: This clinical ...
Detailed Description
OBJECTIVES: Primary * Determine whether immunologic memory to the HER-2/neu (HER2) intracellular domain (ICD) protein has been generated by active immunization with a HER2 ICD plasmid-based vaccine ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of stage III/IV breast cancer
- Completed chemotherapy
- Receiving trastuzumab (Herceptin®) monotherapy
- Successful completion of HER-2/neu (HER2) intracellular domain (ICD) plasmid-based vaccine trial (Protocol 01-9773-D06: "A Phase I Safety and Efficacy Trial of a DNA Plasmid Based Vaccine Encoding the HER-2/neu Intracellular Domain In Subjects With HER-2/neu-Overexpressing Tumors") within the past 3 months
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Male or female (male patients are not excluded)
- Menopausal status not specified
- Zubrod performance status 0
- Unable to bear children (female patients)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No cytoreductive chemotherapy within the past 30 days
- No cytotoxic treatment and/or systemic corticosteroids within the past month
- Concurrent local radiotherapy or hormonal therapy allowed
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00363012
Start Date
April 1 2006
End Date
March 1 2010
Last Update
April 5 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109-1024
2
Tumor Vaccine Group at the University of Washington
Seattle, Washington, United States, 98109