Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      RATIONALE: Vaccines made from peptides may help the body build an effective immune response
      to kill tumor cells. It is not yet known which vaccine is most effective in treating breast
      cancer.

      PURPOSE: This randomized clinical trial is studying the side effects of three different
      vaccine therapies and comparing the vaccines to see how well they work in treating patients
      with previously treated stage II or stage III breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the safety and immunization efficacy of MUC1 and HER-2/neu peptide vaccines
           combined with CpG oligodeoxynucleotide, sargramostim (GM-CSF), or both, as immune
           adjuvants suspended in Freund's incomplete adjuvant in patients with previously treated
           stage II or III adenocarcinoma of the breast.

      Secondary

        -  To describe the impact of immunization on clinical outcomes in patients with
           MUC1-positive breast cancer in terms of disease-free survival and overall survival.

      OUTLINE: Patients are stratified according to Her-2/neu status (positive vs negative).
      Patients are randomized to 1 of 3 treatment arms.

        -  Arm A: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen
           vaccine, two Her-2/neu peptide-based vaccines, and sargramostim (GM-CSF) subcutaneously
           (SC) on day 1.

        -  Arm B: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen
           vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A), and
           CpG oligodeoxynucleotide SC on day 1.

        -  Arm C: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen
           vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A; the
           same as in arm B), GM-CSF, and CpG oligodeoxynucleotide SC on day 1.

      In all arms, treatment repeats every 4 weeks for 6 courses in the absence of disease
      progression or unacceptable toxicity. Patients who complete 6 courses of treatment without
      disease recurrence or a second primary or intolerable toxicity will go to the observation
      phase of the study for up to 2 years. Patients who develop recurrent disease during the
      observational phase will go to the event monitoring phase for up to 2 years.

      Blood samples are collected periodically. Blood samples and tissue samples from the patient's
      most recent surgery are used for correlative studies including immune responses to T helper
      and CTL epitopes by Elispot and tetramer analysis; and antigenic profiling by expression
      analysis of class I HLA antigens, MUC1, and HER-2 in tumor tissue.

      After completion of study treatment, patients are followed periodically until disease
      recurrence or for up to 2 years.
    

Intervention name(s): CpG oligodeoxynucleotide; HER-2/neu peptide vaccine; MUC-1 peptide vaccine; incomplete Freund's adjuvant; sargramostim; immunoenzyme technique; immunologic technique
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Other; Other
Intervention MeSH terms: Vaccines; Sargramostim; Freund's Adjuvant
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IA breast cancer; stage IB breast cancer; triple-negative breast cancer; HER2-positive breast cancer