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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT00841399

Run by

COL George Peoples, MD, FACS

People needed

100

Starts

2001-07-01

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…

• HER2/neu expressing tumor
• 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.
• Immunologically intact with a good performance status
• Identified as being high or intermediate risk for recurrence
• Without evidence of disease
• Completion of all standard first-line therapies (but may still be on hormonal therapy)

You may not qualify if…

• Tumor does not express HER2/neu
• Not HLA-A2+ and/or HLA-A3+
• Anergic
• Receiving immunosuppressive therapy
• In poor health (Karnofsky <60%, ECOG >2 and Tbili >1.5 and creatinine>2)
• Pregnant (beta HCG+)
• Metastatic disease or have refused standard therapies
• Patients enrolled in other experimental protocols may enroll to this study only with the permission of the other study PI.

Where it is running

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

Full record on ClinicalTrials.gov

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