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A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope HER-2/Neu Peptide Vaccine in Subjects Previously Treated for HER-2 Positive Breast Cancer

Phase 1
18 Years
Open (Enrolling)
HER2-positive Breast Cancer, Male Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Thank you

Trial Information

A Phase I Trial of the Safety and Immunogenicity of a Multi-epitope HER-2/Neu Peptide Vaccine in Subjects Previously Treated for HER-2 Positive Breast Cancer


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.


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.


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]

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who experience toxicities of attribution during the course of treatment (grades 3-5 of the NCI's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0) for 2 years.

Outcome Description:

The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

Outcome Time Frame:

Assessed up to 2 years following final immunization

Safety Issue:


Principal Investigator

Keith Knutson, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

Related Keywords:

  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



Mayo Clinic Rochester, Minnesota  55905