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

March 28, 2020 updated by: COL George Peoples, MD, FACS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Pennsylvania
      • Windber, Pennsylvania, United States, 15963
        • Windber Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time period needed to determine the maximum tolerated and optimal biologic doses.

Secondary Outcome Measures

Outcome Measure
Time Frame
The clinical endpoint is time to disease recurrence.
Time Frame: 30 days after each monthly vaccine, then per standard of care for breast cancer.
30 days after each monthly vaccine, then per standard of care for breast cancer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

COL George Peoples, MD, FACS

Collaborators

Uniformed Services University of the Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-2005
  • WRAMC 20280 (Other Identifier: Walter Reed Army Med Center Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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