Phase 2 N=23 Treatment

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

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

Bottom Line

View on ClinicalTrials.gov: NCT00791037 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

May 2017

Primary outcome: Primary: Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: HER-2/neu peptide vaccine (Biological); leukapheresis (Procedure); ex vivo-expanded HER2-specific T cells (Biological); cyclophosphamide (Drug); sargramostim (Biological); laboratory biomarker analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0	—	—
SECONDARY Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT	15	—
SECONDARY Development of CD4+ and CD8+ Epitope Spreading	12	—
SECONDARY Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)	1	—

Summary

This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)

Eligibility Criteria

Inclusion Criteria

Patients with HER2+ Stage IV breast cancer that have been maximally treated and not achieved a complete remission
Patients must have stable or slowly progressive disease state, measurable disease as:
Extraskeletal disease that can be accurately measured >= 10 mm by standard imaging techniques that can include but not limited to computed tomography (CT), positron emission tomography (PET), PET/CT, magnetic resonance imaging (MRI);
Skeletal or bone-only disease which is measurable by fludeoxyglucose (FDG) PET or PET/CT imaging will also be allowed
Patients can be currently 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 2+ or 3+, or documented gene amplification by fluorescence in situ hybridization (FISH) analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
Subjects must have a Performance Status Score (Southwest Oncology Group [SWOG]/Zubrod Scale) = 0, 1 or 2
Patients must be off all immunosuppressive treatments such as chemotherapy or systemic steroid therapy a minimum of 14 days prior to initiation of study (i.e. first vaccination)
Patients on trastuzumab and/or lapatinib must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) equal to or greater than the lower limit of normal for the facility within 90 days of eligibility determination
Men and women of reproductive ability must agree to contraceptive use during the entire study period
Patients must have an expected survival of 6 months
White blood cell (WBC) >= 3000/mm^3
Absolute neutrophil count (ANC) >= 1000/mm^3
Hemoglobin (Hgb) >= 10 mg/dl
Platelets >= 75,000/mm^3
Serum creatinine = 60 ml/min
Total bilirubin = = 18 years old

Exclusion Criteria

Patients with any of the following cardiac conditions:
Symptomatic restrictive cardiomyopathy;
Unstable angina within 4 months prior to enrollment;
New York Heart Association functional class III-IV heart failure on active treatment
Patients with any contraindication to receiving rhuGM-CSF based products
Patients with any clinically significant autoimmune disease uncontrolled with treatment
Patients with a history of brain metastases must have a stable head imaging study within 30 days of eligibility determination; specifically, patients with active brain metastases will not be eligible for study
Patients who are simultaneously enrolled in any other treatment study
Pregnant or breast-feeding women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00791037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.