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

NCT01729884 | Terminated Phase 2

• 4 other identifiers: 7905NCI-2012-02223P30CA015704P50CA138293
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

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

  Wilson score 90% confidence intervals will be reported.

  Up to 4 weeks

• Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets

  Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.

  Up to 4 weeks

Secondary Outcomes (2)

• 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

  Up to 4 weeks

• The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0

  Up to 4 weeks

Study Arms (1)

Treatment (HER-2/neu peptide vaccine)

EXPERIMENTAL

Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.

Biological: HER-2/neu peptide vaccine

Interventions

HER-2/neu peptide vaccine BIOLOGICAL

Given ID

Also known as: HER-2

Treatment (HER-2/neu peptide vaccine)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lupe Salazar

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 20, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

US (1)