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

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary and study completion dates: May 2026 to May 2027

    Study Statusv38

  2. Notable

    Primary and study completion dates: May 2025 to May 2026

    Study Statusv37

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v36

  4. Notable

    Primary and study completion dates: May 2023 to May 2025

    Study Statusv35

  5. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v34

Show 32 earlier versions

  1. Notable

    Primary and study completion dates: May 2022 to May 2023

    Study Statusv33

  2. Minor

    Enrollment target: estimated 12 to confirmed 13

    Study Status, Study Design, Contacts/Locationsv32

  3. Notable

    Primary and study completion dates: May 2021 to May 2022

    Study Statusv31

  4. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v30

  5. Notable

    Primary and study completion dates: May 2020 to May 2021

    Study Statusv29

  6. Notable

    Primary and study completion dates: May 2019 to May 2020

    Study Statusv28

  7. Notable

    Primary and study completion dates: May 2018 to May 2019

    Study Statusv27

  8. Notable

    Primary and study completion dates: May 2017 to May 2018

    Study Statusv26

  9. Notable

    Primary and study completion dates: May 2016 to May 2017

    Study Status, Study Designv25

  10. Notable

    Primary and study completion dates: May 2015 to May 2016

    Study site revised

    Show what changed: Study sites
    Memorial Sloan- Kettering Cancer Center

    Study Status, Contacts/Locations, Referencesv24

  11. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv23

  12. Minor

    Study Status

    Re-verified, no change to tracked fields

    v22

  13. Notable

    Primary and study completion dates: May 2014 to May 2015

    Study Statusv21

  14. Minor

    Study Status

    Re-verified, no change to tracked fields

    v20

  15. Notable

    Primary and study completion dates: May 2013 to May 2014

    Study Statusv19

  16. Minor

    Study Status

    Re-verified, no change to tracked fields

    v18

  17. Notable

    Primary and study completion dates: May 2012 to May 2013

    Study Status, Conditionsv17

  18. Minor

    2 amendments

    2 re-verifications since 2011-05-02, no change to tracked fields

    v15-v16

  19. Notable

    Primary and study completion dates: May 2011 to May 2012

    Study Status, Arms and Interventionsv14

  20. Minor

    Study Status

    Re-verified, no change to tracked fields

    v13

  21. Minor

    Eligibility criteria expanded, about 17 words

    Show what changed: Eligibility criteria
    [...] y the Department of Pathology at MSKCC. HER2 over-expression documented by FISH or by staining 3+ on Herceptestimmunohistochemistry in either the primary or metastatic tumor. Karnofsky performance status > or = to 80%. No treatment for breast cancer within the previous 4 weeks excluding hormone therapy and/or trastuzumab. Patients must have recovered from the toxicity of any prior therapy, and not received major surgery, radiation therapy, corticosteroid therapy or chemotherapy for at least 4 weeks prior to entry into th [...] nt History of known immunodeficiency or autoimmune disease. CurrentAny use [...] [...]

    Study Status, Arms and Interventions, Eligibilityv12

  22. Minor

    Eligibility criteria expanded, about 4 words

    Show what changed: Eligibility criteria
    [...] is permitted.) Age > 18 years Exclusion Criteria: Pregnancy. (Women of child bearing potential must not be pregnant and [...] mune disease. Current use of immunosuppressive medications (ie i.e. corticosteroids). Previous breast cancer vaccine exposure. Active CNS or leptomeningeal tumor. Active infection requiring antibiotic treatment. Anticipated survival of less than 6 months.

    Study Status, Eligibilityv11

  23. Notable

    Primary and study completion dates: May 2010 to May 2011

    Collaborators shortened, about 4 words

    Show what changed: Collaborators
    Breast Cancer Research Foundation

    Study Status, Sponsor/Collaborators, Contacts/Locationsv10

  24. Minor

    2 amendments

    2 re-verifications since 2009-01-29, no change to tracked fields

    v8-v9

  25. Notable

    Primary and study completion dates: May 2009 to May 2010

    Eligibility criteria expanded, about 13 words

    Show what changed: Eligibility criteria
    [...] lly be eligible for this trial. Patients may have measurable disease, evaluable disease or be without evidence of disease. They may be rece [...] lly confirmed) with no evidence of disease or stable disease. Patients may be either off therapy or on hormone therapy and/or trastuzumab. OR AJCC Stage III breast cancer < or = to 36 months post com [...] cancer within the previous 4 weeks excluding hormone therapy and/or trastuzumab. Patients must have recovered from the toxicity of any prio [...]

    Study Status, Eligibilityv7

  26. Minor

    Eligibility criteria expanded, about 55 words

    Show what changed: Eligibility criteria
    Breast cancer patients with AJCC Stage III or metastatic (AJCC Stage IV) disease that over-express HER2 will potentially be eligible for this trial. Patients may have measurable disease or be without evidence of disease. They may be receiving hormonal therapy and they may have already received trast [...] Inclusion Criteria: Patients must have ALL of the features l [...] received surgery, radiation therapy, corticosteroid therapy, chemotherapy or antibody therapy (ie. Trastuzumab)chemotherapy for at least 4 weeks prior to entry into the trial. (Ongoing hormonal therapy and/or trastuzumab administration is [...]

    Study Status, Eligibilityv6

  27. Minor

    Primary completion date: May 2009

    Study Statusv5

  28. Notable

    Primary endpoints: 5 to 1

    Completion date: May 2009; Secondary endpoints: details revised at 1 of 1 entry; Study arms: 0 to 1

    Show what changed: Primary endpoints
    The IgG and IgM antibody response and T cell response to HER2 The primary objectives of this trial are to determine the following endpoints after injection with The toxicities rat HER2 DNA:

    Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measuresv4

  29. Minor

    2 amendments

    2 re-verifications since 2007-04-19, no change to tracked fields

    v2-v3

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00393783
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Breast Cancer
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov