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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

Phase 2
19 Years
Open (Enrolling)
HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

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


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.

Inclusion Criteria:

- Patients with HER2+ stage IV breast cancer that have been maximally treated and not
in a complete remission

- Patients must have measurable disease per imaging studies performed within 60 days of
enrollment as described below:

- Extra skeletal disease that can be measured with conventional or spiral computed
tomography (CT) techniques

- Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG)
positron emission tomography (PET) or magnetic resonance imaging (MRI)

- Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or
bisphosphonate therapy

- HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC)
of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH)

- Patients must be human leukocyte antigen (HLA)-A2 positive

- Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1

- Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic
steroids) 3 weeks prior to first vaccine

- Patients on trastuzumab must have a baseline left ventricular ejection fraction
(LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >=
the lower limit of normal for the facility within 3 months of enrollment to study

- Subjects of reproductive ability must agree to use contraceptives during the entire
study period

Exclusion Criteria:

- White blood cell (WBC) < 3000/mm^3

- Hemoglobin (Hgb) < 10 mg/dl

- Platelets < 100,000/mm^3

- Serum creatinine > 2.0 mg/dl

- Serum bilirubin > 1.5 x upper limit of normal

- Any contraindication to receiving sargramostim (GM-CSF) based vaccine products

- Concurrent enrollment in other treatment studies

- New York Heart Association functional class III-IV heart failure, symptomatic
pericardial effusion, or unstable angina

- Pregnant or breast-feeding women

- History of disorders associated with immunosuppression such as human immunodeficiency
virus (HIV)

- Active brain metastasis

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC

Outcome Description:

Wilson score 90% confidence intervals will be reported.

Outcome Time Frame:

Up to 4 weeks

Safety Issue:


Principal Investigator

Lupe Salazar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109