🏛️ Verified NIH Record • Updated 2026-06-04

Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity (NCT00393783)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response. The immune system consists of different kinds of cells and substances which help fight against infections and inflammation in the body. These antibodies and T-cells are part of the immune system that may also help to fight against tumor cells. One way to make antibodies and stimulate T-cells is to inject the patient with a preparation which contains material that may stimulate the immune system. This process is called an immunization. We are trying to immunize the patient against HER2/neu. In order to participate in this trial, the tumor must have a large amount of HER2/neu on its surface. The injection that the patient will receive in this trial is a piece of DNA made in bacteria which contains the gene for rat HER2. DNA is material which contains the information needed to produce many substances in the body. The HER2 gene encodes for a protein known as HER2.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (23 items).

Location: Memorial Sloan Kettering Cancer Center — New York, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Pregnancy (Women of child bearing potential must not be pregnant and have a normal pregnancy test within 2 weeks of starting treatment.) Woman who may yet bear children and sexually active men must be using appropriate contraception during the course of this study. Patients must be counseled not to become pregnant during the study. Patients must also be counseled that injection of HER2 may have unknown affects on the viability of a future fetus.
  • Nursing
  • Prior cumulative doxorubicin dose \> 360 mg/m2
  • Prior cumulative epirubicin dose \> 600 mg/m2
  • Other active cancers (within the prior five years, excluding non-melanoma skin cancer).
  • Inadequate organ function as defined by any of the following:
  • total white blood cell count of \< 3,000 cells/mm3
  • platelet count \< 100,000/mm3
  • serum creatinine \> 1.5 x upper limit of normal
  • aspartate aminotransferase (AST) \> 2 x the upper limit of normal
  • History of cardiac disease as defined by any of the following:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Memorial Sloan Kettering Cancer Center — New York, New York

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗