Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer

Korábbi kezelés

• 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
  • Symptomatic pericardial effusion
• Patients with any contraindication to receiving rhuGM-CSF based products

Más betegség

• Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use)
• Patients with any seizure disorder
• Patients with any clinically significant autoimmune disease uncontrolled with treatment

Egyéb

• Patients who are simultaneously enrolled in any other treatment study
• Patients who are pregnant or breastfeeding

• Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have:
  • No evidence of disease (NED), or
  • Stable bone only disease
• Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy
• Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollment
• Patients must be at least 28 days post systemic steroids prior to enrollment
• Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 1
• Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
• Estimated life expectancy of more than 6 months
• White blood cells (WBC) >= 3000/mm\^3 (within 30 days of first vaccination)
• Lymphocyte count >= 800/mm\^3 (within 30 days of first vaccination)
• Platelet count >= 75,000/mm\^3 (within 30 days of first vaccination)
• Hemoglobin (Hgb) >= 10 g/dl (within 30 days of first vaccination)
• Serum creatinine <= 1.2 mg/dl or creatinine clearance > 60 ml/min (within 30 days of first vaccination)
• Total bilirubin <= 1.5 mg/dl (within 30 days of first vaccination)
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) <= 2 times upper limit of normal (ULN) (within 30 days of first vaccination)
• Blood glucose < 1.5 ULN (within 30 days of first vaccination)
• All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study