Clinical Trial Detail

- To evaluate how safe giving escalating doses of T cells into patients with advanced HER2-positive breast cancer is.

- To look at how much HER2 specific T cell immunity can be boosted or generated in patients.

- Patients with HER2-positive Stage IV breast cancer that have been maximally treated and not achieved a complete remission

- Patients must have stable or slowly progressive disease, measurable as described below:

-- a) Extraskeletal disease that can be accurately measured = 10 mm by standard imaging techniques that can include but not limited to CT, PET, PET/CT, MRI

-- b) Skeletal or bone-only disease which is measurable by FDG PET or PET/CT imaging will also be allowed

- Patients can be currently receiving trastuzumab (herceptin) and/or lapatinib (Tykerb) and/or hormonal therapy and/or bisphosphonate therapy

- HER2 overexpression in the primary tumor or metastasis by:

-- a) IHC of 2+ or 3+, or

-- b) Documented gene amplification by fluorescence in situ hybridization (FISH) analysis

-- c) If overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH

- Subjects must have a Performance Status Score (SWOG/Zubrod Scale) = 0- 2

- Patients must be off all immunosuppressive treatments such as chemotherapy or systemic steroid therapy a minimum of 14 days prior to the first vaccination

- Patients on trastuzumab (herceptin) and/or lapatinib (Tykerb) must have a baseline LVEF measured by MUGA or echocardiogram (ECHO) equal to or greater than the lower limit of normal for the facility within 90 days of eligibility determination

- Subjects must be = 18 years old

- 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/mm3

- Absolute neutrophil count (ANC) = 1000/mm3

- Hemoglobin (Hgb) = 10 mg/dl

- Platelets = 75,000mm3

- Serum creatinine = 2.0 mg/dl or creatinine clearance > 60 ml/min

- Total bilirubin = 2.5 mg/dl

- Aspartate Aminotransferase (AST)/Serum Glutamic Oxaloacetic Transaminase (SGOT) = 3 times ULN

Other eligibility criteria may apply.

- Patients with any of the following cardiac conditions:

-- a) symptomatic restrictive cardiomyopathy

-- b) unstable angina within 4 months prior to enrollment

-- c) 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

Other exclusion criteria may apply.