Breast CancerPhase 1NCT00393783
Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity
A Phase 1 study testing MAB HER 2 (HERCEPTIN) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MAB HER 2 (HERCEPTIN)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have ALL of the features listed below:
- AJCC Stage IV breast cancer (histologically 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 completion of adjuvant therapy.
- Pathology slides must be reviewed by the Department of Pathology at MSKCC.
- HER2 over-expression by FISH or by staining 3+ on immunohistochemistry in either the primary or metastatic tumor.
- Karnofsky performance status > or = to 80%.
- Patients must have recovered from the toxicity of any prior therapy, and not received major surgery, radiation therapy, or chemotherapy for at least 4 weeks prior to entry into the trial. (Ongoing hormonal therapy and/or trastuzumab administration is permitted.)
- Age > 18 years
Who cannot join
- 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:
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- 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:
- any prior myocardial infarction
- history of documented congestive heart failure
- left ventricular ejection fraction below the normal institutional range
- use of medications for treatment of angina pectoris
- any prior arrhythmia or cardiac valvular disease requiring medication or clinically significant
- History of known immunodeficiency or autoimmune disease.
- Any use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
- Previous breast cancer vaccine exposure
- Active CNS or leptomeningeal tumor
- Active infection requiring antibiotic treatment
- Anticipated survival of less than 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- MAB HER 2 (HERCEPTIN)
- Keywords
- Breast Cancer, Metastatic, HER2, 04-101
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAB HER 2 (HERCEPTIN)Biological
Rat HER2 DNA will be delivered intramuscularly at four different dose levels (0.5mg, 1mg, 3mg, or 6mg) during weeks 1, 4, 7, 10 and 13 for five injections.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HER2 ECD DNA. Receives: Biological: MAB HER 2 (HERCEPTIN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose over four dose levels
Measured: 13 weeks
Secondary outcomes (1)
A secondary endpoint is to observe patients for any evidence of anti-tumor effect.
Measured: at week 19 or at the discretion of the physician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Robson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393783
- Sponsor's protocol ID
- 04-101
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2006
- Last updated
- 8 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity
- ClinicalTrials.gov ID
- NCT00393783
- Acronym / sponsor ID
- 04-101
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Metastatic, HER2, 04-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2006 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MAB HER 2 (HERCEPTIN)HER2 ECD DNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- AJCC Stage IV breast cancer (histologically 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 completion of adjuvant therapy.
- Pathology slides must be reviewed by the Department of Pathology at MSKCC.
- HER2 over-expression by FISH or by staining 3+ on immunohistochemistry in either the primary or metastatic tumor.
- Karnofsky performance status > or = to 80%.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAB HER 2 (HERCEPTIN)Rat HER2 DNA will be delivered intramuscularly at four different dose levels (0.5mg, 1mg, 3mg, or 6mg) during weeks 1, 4, 7, 10 and 13 for five injections. | Biological | 1 |
Primary outcome
The maximum tolerated dose over four dose levels
Time frame: 13 weeks
1 secondary outcome
A secondary endpoint is to observe patients for any evidence of anti-tumor effect.
Time frame: at week 19 or at the discretion of the physician
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Robson, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAB HER 2 (HERCEPTIN) in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose over four dose levels (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.