Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

The objectives of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) in node-negative breast cancer patients. 2. To determine the optimal dose of the immunoadjuvant, GM-CSF, necessary to elicit an in vivo cellular immune response to the peptide vaccine yet limit toxicity. 3. To determine the optimal inoculation schedule to elicit an in vivo cellular immune response to the peptide vaccine. 4. To correlate the efficiency of eliciting an in vivo cellular immune response to the peptide vaccine with the degree of HER2/neu expression in the patient's tumor.

Key facts

Study ID

NCT00854789

Run by

COL George Peoples, MD, FACS

People needed

95

Starts

2002-12-01

Expected to finish

2013-03-01

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Breast cancer and negative lymph nodes
• HLA-A2+ and/or HLA-A3+ to receive the vaccine. HLA-A2-, HLA-A3- patients will be eligible to be included in the control group.
• Immunologically intact with a good performance status (defined below).
• Without evidence of disease.
• Patients may enroll while receiving appropriate hormonal therapy for their disease.
• Completion of all standard first-line therapies (but may still be on hormonal therapy)

You may not qualify if…

• HLA-A2- and/or HLA-A3- patients will not be vaccinated
• Anergic by the Mantoux panel of recall antigens
• Receiving immunosuppressive therapy
• In poor health (Karnofsky <60%, ECOG >2)
• Tbili >1.5 mg/dL and creatinine>2 mg/dL
• Pregnancy (urine HCG)
• Active metastatic disease
• Involved in other experimental protocols (unless approval is first obtained by the other study PI)
• Refusal of standard therapies

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Windber Medical Center — Windber, Pennsylvania, United States

Full record on ClinicalTrials.gov

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