Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841399
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : June 3, 2014
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
COL George Peoples, MD, FACS, Walter Reed Army Medical Center

February 10, 2009
February 11, 2009
June 3, 2014
July 2001
September 2012   (Final data collection date for primary outcome measure)
The primary endpoints are the safety and optimal dosing of the vaccine to induce an in vivo peptide-specific immune response. [ Time Frame: Time period needed to determine the maximum tolerated and optimal biologic doses. ]
Same as current
Complete list of historical versions of study NCT00841399 on Archive Site
The clinical endpoint is time to disease recurrence. [ Time Frame: 30 days after each monthly vaccine, then per standard of care for breast cancer. ]
Same as current
Not Provided
Not Provided
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients
Phase Ib Trial of HER2/Neu Peptide (E75) Vaccine in Breast Cancer Patients at Risk for Recurrence After Surgical and Medical Therapies

The purposes of this study are the following:

  1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75)
  2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine
  3. To evaluate the in vivo cellular immune response to the peptide vaccine
  4. To evaluate time to recurrence in the vaccinated patients vs. matched controls

Breast cancer is the most common malignancy and second most common cause of cancer-specific death among women in the United States. Despite advances in the diagnosis and treatment of breast cancer, one third of the women who develop the disease will die of the disease, accounting for approximately 46,300 deaths/year. While good primary therapies are available to treat early stage breast cancer, there is a substantial failure rate to these therapies in more advanced disease.

Advances in the understanding of the immune response to cancer have lead to the genesis of immunotherapeutic approaches. Specifically, the development of anti-cancer vaccines holds promise as an adjuvant and preventive therapy for patients after both primary surgical and medical treatment for breast cancer, but who are at a high risk for recurrence. Patients with greater than four lymph nodes positive have an 87% chance of recurrence post standard surgical and medical therapies at 10 years. While patients with hormone receptor positive tumors have the option to undergo hormonal therapy, recurrence is especially high among estrogen receptor/progesterone receptor (ER/PR) negative patients. For these patients, currently there is no good treatment option after completion of primary therapy; close surveillance and watchful waiting is the standard.

It is this population of patients that a vaccine strategy to induce cellular immunity would target. We propose to vaccinate these patients with an immunogenic peptide from the HER2/neu protein. If successful, this vaccine strategy could be utilized as an adjuvant to currently accepted first line therapy in future clinical trials.

Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Breast Cancer
Biological: E75 + GM-CSF vaccine
Dose escalation scheme involving three patients each receiving injection of 100, 500, or 1,000 mcg E75 + GM-CSF monthly for 6 months. HLA-A2 and HLA-A3 status determined. HLA-A2+ and HLA-A3+ patients receive the vaccine; HLA-A2- and HLA-A3- enrolled to the control arm.
  • Experimental: E75 + GM-CSF vaccine
    The dose escalation scheme is for three patients to receive each of the doses, 100, 500, and 1,000 mcg of peptide + 250 mcg GM-CSF each month for 6 months until the maximum tolerated dose is determined. Patients who receive the vaccine are HLA-A2+ and/or HLA-A3+. Responses to the vaccine are measured via immunologic assays.
    Intervention: Biological: E75 + GM-CSF vaccine
  • No Intervention: Control/observation
    HLA-A2- and HLA-A3- patients do not receive the E37 + GM-CSF vaccine, but are instead enrolled to the control arm for observation.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2013
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. HER2/neu expressing tumor
  2. HLA-A2+ and/or HLA-A3+ to receive the vaccine. HLA-A2- and/or HLA-A3- patients will be eligible to be included in the control group.
  3. Immunologically intact with a good performance status
  4. Identified as being high or intermediate risk for recurrence
  5. Without evidence of disease
  6. Completion of all standard first-line therapies (but may still be on hormonal therapy)

Exclusion Criteria:

  1. Tumor does not express HER2/neu
  2. Not HLA-A2+ and/or HLA-A3+
  3. Anergic
  4. Receiving immunosuppressive therapy
  5. In poor health (Karnofsky <60%, ECOG >2 and Tbili >1.5 and creatinine>2)
  6. Pregnant (beta HCG+)
  7. Metastatic disease or have refused standard therapies
  8. Patients enrolled in other experimental protocols may enroll to this study only with the permission of the other study PI.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
WRAMC 20280 ( Other Identifier: Walter Reed Army Med Center Institutional Review Board )
Not Provided
Not Provided
COL George Peoples, MD, FACS, Walter Reed Army Medical Center
COL George Peoples, MD, FACS
Uniformed Services University of the Health Sciences
Principal Investigator: George E Peoples, MD Cancer Vaccine Development Program
Walter Reed Army Medical Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP