Breast CancerPhase 2NCT00524277
Vaccine Therapy in Treating Patients With Breast Cancer
A Phase 2 study testing GP2 peptide + GM-CSF vaccine, GM-CSF (sargramostim) and AE37 + GM-CSF vaccine in people with Breast Cancer, run by San Antonio Military Medical Center at 13 sites in 3 countries.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- GP2 peptide + GM-CSF vaccine, GM-CSF (sargramostim) and AE37 + GM-CSF vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Jan 2007to 31 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer. The latter is defined by any one of the following criteria:
- T2 disease
- Grade 3 disease
- Lymphovascular invasion
- Estrogen receptor- or progesterone receptor-negative disease
- HER2/neu-expressing tumor (immunohistochemistry [IHC] 3+ and/or amplified fluorescence in situ hybridization [FISH] >2.2, or N0 (i+))
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- HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)
- Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)
- Clinically cancer-free (no evidence of disease)
- Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies
- Good performance status (as defined in Exclusion Criteria)
- Capable of informed consent
- Female or male
- Menopausal status not specified
- Immunologically intact by recall anergy testing
- Negative pregnancy test
- See Disease Characteristics
Who cannot join
- HER2/neu-negative breast cancers (IHC 0)
- Clinical and/or radiographic evidence of residual or persistent breast cancer
- Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
- In poor health (Karnofsky <60%, ECOG >/-2)
- Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)
- Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
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- Pregnancy (urine hCG)
- Breast feeding
- History of autoimmune disease
- Involved in other experimental protocols (except with permission of the other study PI)
- PATIENT CHARACTERISTICS:
- Karnofsky 0-60% or ECOG ≥ 2
- Total bilirubin > 1.8 g/dL
- Creatinine > 2.0 g/dL
- Hemoglobin < 10.0 g/dL
- Platelet count < 50,000/mm³
- WBC< 2,000/mm³
- Active pulmonary disease requiring medication that includes multiple inhalers
- Pregnancy
- Breastfeeding
- History of autoimmune disease
- PRIOR CONCURRENT THERAPY:
- Concurrent immunosuppressive therapy including chemotherapy, steroids, or methotrexate
- Concurrent participation in another experimental treatment (except with permission of the other study investigator)
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States11 sites
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
MedStar Good Samaritan Hospital Cancer Center
Baltimore, Maryland, 21239
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544-4752
San Antonio Army Medical Center
Fort Sam Houston, Texas, 78234-6200
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
STOH Clinical Research
San Antonio, Texas, 78229
Madigan Army Medical Center - Tacoma
Tacoma, Washington, 98431-5000
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.
PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.
Read the detailed description
OBJECTIVES:
- To determine if the GP2 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-positive, HER2/neu-positive, node-positive, or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, sargramostim (GM-CSF), alone.
- To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF, alone.
- To monitor the invitro and invivo immunologic responses to the vaccines and correlate these responses with the clinical outcomes.
- To monitor for any unexpected toxicities with the vaccines.
OUTLINE: This is a multicenter study. Patients are stratified according to nodal status. Patients are randomized to 1 of 4 treatment arms.
- Arm I: HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations.
- Arm II: HLA-A2-positive patients receive solely GM-CSF ID
- Arm III: HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.
- Arm IV: HLA-A2-negative patients receive solely GM-CSF ID
After completion of study therapy, patients are followed every 3 months for the first 24 months and then every 6 months for an additional 36 months.
Booster inoculations are administered at 12, 18, 24, and 30 months from the date of patients' enrollment into the study. One booster inoculation is administered at each timepoint (+/- 2 weeks) and will be the same inoculation (vaccine or GM-CSF only) as what patients received during their regular inoculation series.
- Conditions
- Breast Cancer
- Being tested
- GP2 peptide + GM-CSF vaccine, GM-CSF (sargramostim), AE37 + GM-CSF vaccine
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP2 peptide + GM-CSF vaccineBiological
Also called GM-CSF (sargramostim)
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
GM-CSF (sargramostim)Biological
GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations
AE37 + GM-CSF vaccineBiological
Also called GM-CSF (sargramostim)
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
GM-CSF (sargramostim)Biological
Given intradermally every 3-4 weeks for a total of up to 6 inoculations
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | HLA-A2-positive patients receive GP2 peptide + GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations. Receives: Biological: GP2 peptide + GM-CSF vaccine |
| Arm II | Active comparator | HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations. Receives: Biological: GM-CSF (sargramostim) |
| Arm III | Experimental | HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations. Receives: Biological: AE37 + GM-CSF vaccine |
| Arm IV | Active comparator | HLA-A2-negative patients receive GM-CSF ID ID every 3-4 weeks for a total of up to 6 inoculations Receives: Biological: GM-CSF (sargramostim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease recurrence
The following will be compared:
- disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone
- disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone
- disease recurrence rates between all four arms of the trial.
Measured: Five years (from date of enrollment to the study through the end of the follow-up period)
Secondary outcomes (2)
Safety
Inoculations will be immediately halted if any serious adverse reactions occur which, when based upon appropriate judgment of the PI, are determined to jeopardize the patient or require medical or surgical intervention. Any death or grade 4 adverse drug experience found to be directly related to the experimental vaccine will result in suspension of patient enrollment to the study.
Measured: Local and systemic reactions to each inoculation will be monitored every six months during the regular inoculation series and the booster series.
Immune Response
Immune response will be measured by proliferation assays, dimer assays, and ELISPOT. Delayed type hypersensitivity reactions will be compared between the vaccinated group and GM-CSF-only group.
Measured: Immune response will be measured after every monthly inoculation in the regular inoculation series and after each inoculation in the booster series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJan 2007
- Primary completion31 Dec 2014
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Antonio Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- NuGenerex Immuno-Oncology, Norwell, Inc.
- Responsible party
- Principal investigator, COL George Peoples, MD, FACS, San Antonio Military Medical Center
- Investigators
- Elizabeth A Mittendorf, MD, FACS, Principal investigator, UT M.D. Anderson Cancer CenterGeorge E Peoples, MD, FACS, Study director, Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524277
- Sponsor's protocol ID
- CDR0000562261
- Other IDs
- BAMC-C.2007.098, WRNMMC-20225
- Status last verified
- Mar 2020
- First submitted
- 31 Aug 2007
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mittendorf EA, Alatrash G, Xiao H, Clifton GT, Murray JL, Peoples GE. Breast cancer vaccines: ongoing National Cancer Institute-registered clinical trials. Expert Rev Vaccines. 2011 Jun;10(6):755-74. doi: 10.1586/erv.11.59.
PubMed 21692698Sears AK, Perez SA, Clifton GT, Benavides LC, Gates JD, Clive KS, Holmes JP, Shumway NM, Van Echo DC, Carmichael MG, Ponniah S, Baxevanis CN, Mittendorf EA, Papamichail M, Peoples GE. AE37: a novel T-cell-eliciting vaccine for breast cancer. Expert Opin Biol Ther. 2011 Nov;11(11):1543-50. doi: 10.1517/14712598.2011.616889. Epub 2011 Sep 6.
PubMed 21895539Jackson DO, Trappey FA, Clifton GT, Vreeland TJ, Peace KM, Hale DF, Litton JK, Murray JL, Perez SA, Papamichail M, Mittendorf EA, Peoples GE. Effects of HLA status and HER2 status on outcomes in breast cancer patients at risk for recurrence - Implications for vaccine trial design. Clin Immunol. 2018 Oct;195:28-35. doi: 10.1016/j.clim.2018.06.008. Epub 2018 Jul 17.
PubMed 30025819
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00524277
- Acronym / sponsor ID
- CDR0000562261
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- San Antonio Military Medical CenterUS federal agency
- Collaborators
- NuGenerex Immuno-Oncology, Norwell, Inc.
- Study start
- Jan 2007
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 3 Sep 2007 (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.
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.
PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.
Detailed description
OBJECTIVES:
- To determine if the GP2 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-positive, HER2/neu-positive, node-positive, or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, sargramostim (GM-CSF), alone.
- To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF, alone.
- To monitor the invitro and invivo immunologic responses to the vaccines and correlate these responses with the clinical outcomes.
- To monitor for any unexpected toxicities with the vaccines.
OUTLINE: This is a multicenter study. Patients are stratified according to nodal status. Patients are randomized to 1 of 4 treatment arms.
- Arm I: HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations.
- Arm II: HLA-A2-positive patients receive solely GM-CSF ID
- Arm III: HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.
- Arm IV: HLA-A2-negative patients receive solely GM-CSF ID
After completion of study therapy, patients are followed every 3 months for the first 24 months and then every 6 months for an additional 36 months.
Booster inoculations are administered at 12, 18, 24, and 30 months from the date of patients' enrollment into the study. One booster inoculation is administered at each timepoint (+/- 2 weeks) and will be the same inoculation (vaccine or GM-CSF only) as what patients received during their regular inoculation series.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: GP2 peptide + GM-CSF vaccineHLA-A2-positive patients receive GP2 peptide + GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations. |
| Arm II | Active comparator | Biological: GM-CSF (sargramostim)HLA-A2-positive patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations. |
| Arm III | Experimental | Biological: AE37 + GM-CSF vaccineHLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations. |
| Arm IV | Active comparator | Biological: GM-CSF (sargramostim)HLA-A2-negative patients receive GM-CSF ID ID every 3-4 weeks for a total of up to 6 inoculations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer. The latter is defined by any one of the following criteria:
- HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)
- Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)
- Clinically cancer-free (no evidence of disease)
- Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies
Key exclusion criteria (24 listed)
- HER2/neu-negative breast cancers (IHC 0)
- Clinical and/or radiographic evidence of residual or persistent breast cancer
- Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
- In poor health (Karnofsky <60%, ECOG >/-2)
- Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)
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 |
|---|---|---|
| GP2 peptide + GM-CSF vaccineAlso: GM-CSF (sargramostim)Given intradermally every 3-4 weeks for a total of up to 6 inoculations | Biological | Arm I |
| GM-CSF (sargramostim)GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations | Biological | Arm II |
| AE37 + GM-CSF vaccineAlso: GM-CSF (sargramostim)Given intradermally every 3-4 weeks for a total of up to 6 inoculations | Biological | Arm III |
| GM-CSF (sargramostim)Given intradermally every 3-4 weeks for a total of up to 6 inoculations | Biological | Arm IV |
Primary outcome
Disease recurrence
Time frame: Five years (from date of enrollment to the study through the end of the follow-up period)
The following will be compared: 1. disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone 2. disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone 3. disease recurrence rates between all four arms of the trial.
2 secondary outcomes
Safety
Time frame: Local and systemic reactions to each inoculation will be monitored every six months during the regular inoculation series and the booster series.
Immune Response
Time frame: Immune response will be measured after every monthly inoculation in the regular inoculation series and after each inoculation in the booster series
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 21692698Mittendorf EA, Alatrash G, Xiao H, Clifton GT, Murray JL, Peoples GE. Breast cancer vaccines: ongoing National Cancer Institute-registered clinical trials. Expert Rev Vaccines. 2011 Jun;10(6):755-74. doi: 10.1586/erv.11.59.
- Results publication: PubMed 21895539Sears AK, Perez SA, Clifton GT, Benavides LC, Gates JD, Clive KS, Holmes JP, Shumway NM, Van Echo DC, Carmichael MG, Ponniah S, Baxevanis CN, Mittendorf EA, Papamichail M, Peoples GE. AE37: a novel T-cell-eliciting vaccine for breast cancer. Expert Opin Biol Ther. 2011 Nov;11(11):1543-50. doi: 10.1517/14712598.2011.616889. Epub 2011 Sep 6.
- Derived from this study: PubMed 30025819Jackson DO, Trappey FA, Clifton GT, Vreeland TJ, Peace KM, Hale DF, Litton JK, Murray JL, Perez SA, Papamichail M, Mittendorf EA, Peoples GE. Effects of HLA status and HER2 status on outcomes in breast cancer patients at risk for recurrence - Implications for vaccine trial design. Clin Immunol. 2018 Oct;195:28-35. doi: 10.1016/j.clim.2018.06.008. Epub 2018 Jul 17.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink 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.
Elizabeth A Mittendorf, MD, FACS principal investigator
UT M.D. Anderson Cancer Center
George E Peoples, MD, FACS study director
Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GP2 peptide + GM-CSF vaccine, GM-CSF (sargramostim) and AE37 + GM-CSF vaccine in people with Breast Cancer, run by San Antonio Military Medical Center at 13 sites in 3 countries.
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 17 inclusion and 24 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: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany, Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease recurrence (time frame: Five years (from date of enrollment to the study through the end of the follow-up period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524277, which also lists 3 linked publications.
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 30 Mar 2020.