Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer
The purpose of this study is to look at the safety and immune response to a vaccine used in
 patients previously treated for HER2 (human epidermal growth factor receptor 2) positive
 breast cancer.
PRIMARY OBJECTIVES:

 I. To determine the safety profile of a peptide-based vaccine targeting HER-2/neu, in
 patients with stage II/III HER-2 positive breast cancer.

 II. To determine the ability of this vaccination protocol to elicit an immune response as
 measured by activated HER-2/neu-specific T lymphocytes or high-affinity antibodies.

 SECONDARY OBJECTIVES:

 I. To compile descriptive follow-up data regarding vital status and disease recurrence.

 II. To determine if HER-2/neu peptide 885 generates a T cell response that is specific to
 HER-2/neu or is cross-reactive with epidermal growth factor receptor (EGFR) protein.

 III. To determine if the human leukocyte antigen (HLA)-DR epitopes contain HLA class I
 embedded epitopes.

 OUTLINE:

 Patients receive HER-2/neu peptide vaccine intradermally (ID) every 28 days for up to 6
 courses in the absence of disease progression or unacceptable toxicity.

 After completion of study treatment, patients are followed up for up to 2 additional years.
Inclusion Criteria:

 -  Histological confirmation of primary breast cancer, stage II or III, completely
 resected; Note: history of a local recurrence allowable if also completely resected

 -  Prior diagnosis of HER-2 positive primary breast cancer using American Society of
 Clinical Oncologists (ASCO)/College of American Pathologists (CAP) guidelines (either
 by evidence of 3+ immunohistochemical staining or with in situ hybridization [FISH]
 amplification)

 -  Completion of surgery +/- radiation at least 30 days prior to registration

 -  Must have received mastectomy or lumpectomy plus radiation

 -  Must have received either neoadjuvant and/or adjuvant chemotherapy for treatment of
 breast cancer

 -  Must have received either neoadjuvant and/or adjuvant trastuzumab for treatment of
 breast cancer

 -  All chemotherapy, trastuzumab, and/or corticosteroids must be completed at least 90
 days prior to registration; Note: hormonal therapy and bisphosphonates may be ongoing

 -  Clinically without any evidence of disease recurrence/progression (per practice
 guidelines for breast cancer)

 -  Absolute neutrophil count (ANC) >= 1500/mm^3

 -  Platelet count >= 75,000/mm^3

 -  Hemoglobin >= 9.0 g/dL

 -  Creatinine =< 2 x upper limit of normal (ULN)

 -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2
 x ULN

 -  Albumin >= 3 g/dL

 -  Negative pregnancy test done =< 7 days prior to registration, for women of
 childbearing potential only

 -  Capable of understanding the investigative nature, potential risks, and benefits of
 the study

 -  Capable of providing valid informed consent

 -  Willing to return to enrolling institution (Mayo Clinic Rochester) for all study
 visits (immunizations, blood draws, etc)

 -  Willing to employ adequate contraception from the time of registration through 6
 months after the final vaccine cycle; Note: adequate contraception methods include
 birth control pills, barrier device, intrauterine device

 -  Willing to provide blood samples for correlative research purposes

 -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

 -  Willing to receive a tetanus vaccination if you have not had one within the past year

 Exclusion Criteria:

 Any prior lapatinib or pertuzumab treatment

 Any of the following because this study involves an investigational agent whose genotoxic,
 mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

 -  Pregnant women

 -  Nursing women unwilling to stop breast feeding

 -  Men or women of child bearing potential who are unwilling to employ adequate
 contraception from the time of registration through 6 months after the final vaccine
 cycle Co-morbid systemic illnesses or other severe concurrent disease which, in the
 judgment of the investigator, would make the patient inappropriate for entry into this
 study or interfere significantly with the proper assessment of safety and toxicity of
 the prescribed regimens Immunocompromised patients including patients known to be
 human immunodeficiency virus (HIV) positive or those on chronic steroids; Note: must
 be off systemic steroids at least 90 days prior to registration; topical steroids or
 steroid eye drops are permitted Uncontrolled intercurrent illness including, but not
 limited to, ongoing or active infection, symptomatic congestive heart failure,
 unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
 that would limit compliance with study requirements

 Uncontrolled acute or chronic medical conditions including, but not limited to the
 following:

 -  Active infection requiring antibiotics

 -  Congestive heart failure with New York Heart Association class III or IV; moderate to
 severe objective evidence of cardiovascular disease

 -  Myocardial infarction or stroke within previous 6 months Receiving any other
 investigational agent Other active malignancy at time of registration or within the
 last three years prior to registration; EXCEPTIONS: non-melanoma skin cancer or
 carcinoma-in-situ (eg of cervix, prostate); NOTE: if there is a history of prior
 malignancy, they must not be receiving other specific treatment (cytotoxics,
 monoclonal antibodies, small molecule inhibitors) for their cancer Known history of
 autoimmune disease, including Type I diabetes Any prior hypersensitivity or adverse
 reaction to granulocyte-macrophage colony-stimulating factor (GM-CSF) History of
 trastuzumab-related cardiac toxicity requiring interruption or discontinuation of
 therapy, even if left ventricular ejection fraction (LVEF) fully recovered Baseline
 LVEF with a value below 55% Failure to fully recover from acute, reversible effects of
 prior chemotherapy regardless of interval since last treatment History of myocardial
 infarction =< 168 days (6 months) prior to registration, or congestive heart failure
 requiring use of ongoing maintenance therapy for life-threatening ventricular
 arrhythmias Bilateral invasive breast cancer, either synchronous or metachronous;
 Note: ductal carcinoma in situ in the contralateral breast is permissible