NCT00343109

Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer

Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells

Detailed description

PRIMARY OBJECTIVES: 1\. To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine. SECONDARY OBJECTIVES: 1. To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab. 2. To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab. 1. To determine the incidence of the development of T cell immunity specific for the HER2 ICD. 2. To determine the incidence of the development of intramolecular epitope spreading. 3. To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response generated with immunization. 3. To assess whether there is an association between RFS and the development of an immune response (HER2 specific T cell immunity and/or the development of intramolecular epitope spreading). OUTLINE: Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally (ID) once monthly for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 4, 8, and 12 months and then annually thereafter for up to 5 years.

Conditions

• HER2-positive Breast Cancer
• Male Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HER-2/neu intracellular domain protein	Given ID
PROCEDURE	leukapheresis	Optional correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
BIOLOGICAL	sargramostim	Given ID
OTHER	immunologic technique	Correlative studies
BIOLOGICAL	synthetic tumor-associated peptide vaccine therapy	Given ID

Timeline

• Start date: 2004-03-01
• Primary completion: 2015-06-01
• First posted: 2006-06-22
• Last updated: 2020-02-12

Locations

1 site across 1 country: United States