Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01729884|
Recruitment Status : Terminated (Study ended early due to slow enrollment)
First Posted : November 20, 2012
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|HER2-positive Breast Cancer Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer||Biological: HER-2/neu peptide vaccine||Phase 2|
I. To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL) peptide-based vaccine.
II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based vaccine and characterize their function.
I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).
Patients receive HER-2/neu peptide vaccine intradermally (ID) once monthly for 3 months.
After completion of study treatment, patients are followed up at 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2013|
Experimental: Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
Biological: HER-2/neu peptide vaccine
Other Name: HER-2
- Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC [ Time Frame: Up to 4 weeks ]Wilson score 90% confidence intervals will be reported.
- Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets [ Time Frame: Up to 4 weeks ]Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.
- The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 4 weeks ]All, severe or worse, serious and related events will be quantified.
- The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0 [ Time Frame: Up to 4 weeks ]All, severe or worse, serious and related events will be quantified.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729884
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Lupe Salazar||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|