Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: HER-2 Protein Vaccine in Treating Women With Breast Cancer

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the safety of HER-2 protein AutoVac™ in women with breast cancer.
  Secondary
  -  Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients.
  -  Determine the kinetics of the immune response to HER-2/neu in patients treated with this drug.
  OUTLINE: This is an open-label, multicenter study.
  Patients receive HER-2 protein AutoVac™ intramuscularly at weeks 0, 2, 6, and 10 in the absence of unacceptable toxicity.
  Patients are followed for up to 6 weeks.
  PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following:
  -  Metastatic disease currently in complete or partial response or stable disease
  -  Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy
  -  Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria:
  -  Stage IIB with involvement of at least 4 nodes
  -  Stage IIIA (T3 disease with involvement of at least 4 nodes)
  -  Any stage IIIB or IIIC disease
  -  Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere)
  -  1+, 2+, or 3+ HER2/neu expression by immunohistochemistry
  -  Treatment with trastuzumab (Herceptin®) not clinically indicated
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Sex
  -  Female
  Menopausal status
  -  Not specified
  Performance status
  -  ECOG 0-1
  Life expectancy
  -  At least 6 months
  Hematopoietic
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin at least 10 g/dL
  -  Absolute neutrophil count at least 1,500/mm^3
  Hepatic
  -  ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases)
  -  Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease)
  Renal
  -  Creatinine no greater than 2 mg/dL
  Cardiovascular
  -  No history of significant cardiovascular disease
  -  No myocardial infarction within the past 6 months
  -  No poorly controlled cardiac arrhythmia
  -  No New York Heart Association class III or IV heart disease
  -  LVEF at least 50% by MUGA
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix
  -  No concurrent severe autoimmune disease
  -  No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  More than 4 months since prior trastuzumab
  -  No prior anticancer vaccine therapy
  -  No concurrent trastuzumab
  -  No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins)
  Chemotherapy
  -  More than 4 weeks since prior chemotherapy
  -  No concurrent low-dose methotrexate or cyclophosphamide
  -  No concurrent cytotoxic chemotherapy
  Endocrine therapy
  -  See Disease Characteristics
  -  No concurrent corticosteroids
  -  Topical or inhaled steroids are allowed
  -  No changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent)
  Radiotherapy
  -  More than 3 months since prior radiotherapy involving more than 25% of the bone marrow
  -  No concurrent radiotherapy
  Surgery
  -  See Disease Characteristics
  -  No prior bilateral breast procedures
  Other
  -  More than 4 weeks since prior immunosuppressive therapy
  -  More than 30 days since prior investigational agents or clinical trial participation
  -  No other concurrent experimental or investigational agents
  -  No concurrent cyclosporine
  -  No concurrent immunosuppressive agents

Relevance to patient case: not relevant