• Safety and systemic toxicity of infusing HER2-specific T cells as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 [ Time Frame: Before each HER2/neu peptide vaccine; before chemotherapy infusion on day -1, weekly T cell infusions beginning on day 1, 1 month following final T cell infusion, and 2 and 4 months after first booster vaccine ] [ Designated as safety issue: Yes ]
  Defined as safe if at least 75% of patients are able to receive all 3 infusions without dose-limiting toxicity (DLT), any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding constitutional, pulmonary, or dermatology/skin categories) or any incidence of Grade 4 toxicity (excluding reversible Grade 4 blood/bone marrow category after cyclophosphamide).
  
  
• Anti-tumor effect after T-cell infusion as determined by standard imaging criteria for evaluation and endpoint definitions for solid tumor response assessment [ Time Frame: Every 3 months for 1 year, every 4 months for the following year, and then twice a year thereafter ] [ Designated as safety issue: No ]
  Analysis of the data will include determination of complete and partial response rates, as well as stable and progressive disease. Results will be tabulated and 95% confidence intervals for these response rates will be calculated.
  
  

• 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 [ Time Frame: Baseline and 1 year following the last infusion ] [ Designated as safety issue: No ]
  
• Development of CD4+ and CD8+ epitope spreading [ Time Frame: Every 3 months for 1 year, every 4 months for the following year, and then twice a year thereafter ] [ Designated as safety issue: No ]
  
• Response of skeletal or bone-only disease by FDG-PET and according to European Organization for Research and Treatment for Cancer (EORTC) [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  

PRIMARY OBJECTIVES:

I. To evaluate the safety of infusing escalating doses of HER2 specific T cells into patients with advanced HER2+ breast cancer using ex vivo expanded autologous T cells.

SECONDARY OBJECTIVES:

I. To investigate to what extent HER2 specific T cell immunity can be boosted or generated in individuals after infusion of HER2 specific T cells.

II. To evaluate how long T cell immune augmentation persists in vivo after adoptive transfer of HER2 specific T cells and subsequent booster immunizations.

III. To determine the development of CD4+ and CD8+ epitope spreading after adoptive transfer of HER2 specific T cells.

TERTIARY OBJECTIVES:

I. To investigate the potential anti-tumor effects of HER2 specific T cells in patients with advanced HER2+ breast cancer.

OUTLINE: This is a phase I/II, dose-escalation study of ex vivo-expanded HER2-specific autologous T cells.

Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) intradermally (ID) on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.

Patients receive cyclophosphamide intravenously (IV) once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.

While on the study, patients may continue their standard-of-care (non-research) treatment with trastuzumab and/or lapatinib IV weekly or every 3 weeks, except for 7 days before the cyclophosphamide dose and at least 7 days after receiving the second T cell vaccine. (Trastuzumab and lapatinib are not required or provided in this study.)

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for the following year, and then twice a year thereafter. This consists of blood collection and contact with patients physician.