Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer

University of Washington

Status and phase

Terminated

Phase 2

Conditions

Male Breast Cancer

HER2-positive Breast Cancer

Recurrent Breast Cancer

Stage IV Breast Cancer

Treatments

Biological: HER-2/neu peptide vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01729884

P50CA138293 (U.S. NIH Grant/Contract)

7905 (Other Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

NCI-2012-02223 (Registry Identifier)

Details and patient eligibility

About

This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

Full description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).

OUTLINE:

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.

Enrollment

3 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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) analysis
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