Breast CancerPhase 1NCT02204098
Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy
A Phase 1 study testing Mammaglobin-A DNA Vaccine and Optional biopsy in people with Breast Cancer and Breast Carcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Carcinoma, Malignant Neoplasm of Breast
- What is being tested?
- Mammaglobin-A DNA Vaccine and Optional biopsy
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2015to 31 Aug 2028
- 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
- A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
- Newly diagnosed histologically confirmed invasive breast cancer.
- Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2- (0 or 1+ by IHC or FISH negative for amplification) breast cancer by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Patients with T1c tumors are eligible if they are considered candidates for neoadjuvant endocrine therapy or chemotherapy
- At least 1 measurable lesion.
- Candidate for neoadjuvant endocrine therapy or chemotherapy.
- At least 18 years of age.
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate organ and marrow function no more than 28 days prior to the start of neoadjuvant endocrine therapy or chemotherapy as defined below:
- WBC ≥3,000/μL
- absolute neutrophil count ≥1,500/μL
- platelets ≥100,000/μL
- total bilirubin ≤institutional upper limit of normal
- AST/ALT ≤2.5 X institutional upper limit of normal
- creatinine ≤ institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine above IULN
- Postmenopausal or premenopausal. NOTE: Postmenopausal women, verified by: (1) bilateral surgical oophorectomy, or (2) no spontaneous menses ≥ 1 year or (3) no menses for <1 year with FSH and estradiol levels in postmenopausal range, according to institutional standards. Premenopausal women, verified by: (1) regular menses, or (2) FSH and estradiol levels in premenopausal range, according to institutional standards.
- Able to understand, and willing to sign a written informed consent document.
- Confirmation that primary tumor expresses mammaglobin-A by IHC.
- Clinical assessment by treating physician that the patient is responding to neoadjuvant therapy or umor Ki67 value is ≤ 10% after 14 days
Who cannot join
- A patient will be ineligible for inclusion in this study if ANY of the following criteria apply:
- Received any of the following for treatment of this cancer (except for the neoadjuvant endocrine therapy or chemotherapy specified within this protocol):
- Surgery
- Radiation therapy
- Chemotherapy
- Biotherapy
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- Hormonal therapy
- Investigational agent Note that subjects who do not respond initially to endocrine therapy may receive chemotherapy and remain on study.
- Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days.
- Known metastatic disease.
- Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
- Prior axillary lymph node sampling (sentinel lymph node biopsy or axillary lymph node dissection). FNA or core needle biopsy of axillary lymph node is acceptable.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable. Any patients receiving steroids should be discussed with the PI to determine if eligible.
- Pregnant or breastfeeding. A negative serum or pregnancy test is required no more than 7 days before study entry, and patients must be willing to employ adequate contraception. Women of childbearing potential must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Known HIV-positive status. These patients are ineligible because of the potential inability to generate an immune response to vaccines.
- Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered.
- Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for the eligible injection sites (left and right medial deltoid region) exceeds 40 mm
- Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
- Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
- Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, EKG, and/or laboratory screening test
- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
- Syncopal episode within 12 months of screening
- Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1B Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in ER+, HER2- Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy or Chemotherapy
The purpose of this research study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way to generate an immune response to breast cancer cells. There is evidence that an immune response may be a way to fight cancer. In addition to evaluating the safety of the mammaglobin-A injection, this study is also looking at the immune response that the participant's body has after each injection.
- Being tested
- Mammaglobin-A DNA Vaccine, Optional biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammaglobin-A DNA VaccineBiological
Optional biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:Neoadjuvant endocrine therapy alone | Active comparator | * Will be treated with standard of care adjuvant endocrine therapy as determined by their treating physician
* Optional biopsy approximately 14 days following initiation of neoadjuvant therapy Receives: Procedure: Optional biopsy |
| Cohort 2:Neoadjuvant endocrine + mammaglobin-A DNA vaccine | Experimental | * Will be treated with standard of care adjuvant endocrine therapy
* Optional biopsy approximately 14 days following initiation of neoadjuvant therapy
* Treated with 4 mg of mammaglobin-A DNA vaccine at 3 time points (Days 28, 56, and 84)
* All study injections will be administered using a TriGrid electroporation device Receives: Biological: Mammaglobin-A DNA Vaccine; Procedure: Optional biopsy |
| Cohort 3: Neoadjuvant chemotherapy alone | Active comparator | * Will be treated with standard of care neoadjuvant chemotherapy as determined by their treating physician
* If archival tissue not sufficient, a research biopsy to obtain primary tissue must be done prior to day 28
* Subjects who begin neoadjuvant endocrine therapy but are determined to not be responding at the Day 14 biopsy may begin chemotherapy treatment, at the discretion of the treating physician. These subjects may be enrolled in cohort 3 Receives: Procedure: Optional biopsy |
| Cohort 4: Neoadjuvant chemotherapy + mammoglobin-A DNA vaccine | Experimental | * Will be treated with standard of care neoadjuvant chemotherapy as determined by their treating physician
* If archival tissue not sufficient, a research biopsy to obtain primary tissue must be done prior to day 28
* Treated with 4 mg of mammaglobin-A DNA vaccine at 3 time points (Days 28, 56, and 84)
* All study injections will be administered using a TriGrid electroporation device
* Subjects who begin neoadjuvant endocrine therapy but are determined to not be responding at the Day 14 biopsy may begin chemotherapy treatment, at the discretion of the treating physician. These subjects may be enrolled in either cohort 4 Receives: Biological: Mammaglobin-A DNA Vaccine; Procedure: Optional biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the number of participants who experience an adverse event
Assessment of plasmid DNA safety will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial. The following parameters will be assessed following vaccination:
- Local signs and symptoms
- Systemic signs and symptoms
- Laboratory evaluations, including blood counts and serum chemistries
- Adverse and serious adverse events
Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0
Measured: Day 126 (+/- 7days)
Secondary outcomes (3)
Immune response
ELISPOT analyses and intracellular cytokine expression analyses using multi-parameter flow cytometry, and peptide MHC tetramer analyses will be performed. Peripheral blood will be obtained at two independent time points before vaccination (Pre-study, and Day 28 +/- 7 days), and at four independent time points following vaccination (Day 56 +/- 7 days, Day 84 +/- 7 days, Day 112 +/- 7 days, and Day 365 +/- 28 days).
Measured: Week 52
Progression-free survival (PFS)
◦Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one more new lesions PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: 5 years
Overall survival (OS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start7 Jan 2015
- Primary completion6 Apr 2022
- Study completion31 Aug 2028 (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 Washington University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Rising Tide Foundation, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- William Gillanders, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204098
- Sponsor's protocol ID
- 201407100
- Other IDs
- W81XWH-15-1-0101
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in ER+, HER2- Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy or Chemotherapy
- ClinicalTrials.gov ID
- NCT02204098
- Acronym / sponsor ID
- 201407100
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Rising Tide Foundation, United States Department of Defense
- Study start
- 7 Jan 2015 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 30 Jul 2014 (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 research study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way to generate an immune response to breast cancer cells. There is evidence that an immune response may be a way to fight cancer. In addition to evaluating the safety of the mammaglobin-A injection, this study is also looking at the immune response that the participant's body has after each injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1:Neoadjuvant endocrine therapy alone | Active comparator | Procedure: Optional biopsy* Will be treated with standard of care adjuvant endocrine therapy as determined by their treating physician * Optional biopsy approximately 14 days following initiation of neoadjuvant therapy |
| Cohort 2:Neoadjuvant endocrine + mammaglobin-A DNA vaccine | Experimental | Biological: Mammaglobin-A DNA Vaccine, Procedure: Optional biopsy* Will be treated with standard of care adjuvant endocrine therapy * Optional biopsy approximately 14 days following initiation of neoadjuvant therapy * Treated with 4 mg of mammaglobin-A DNA vaccine at 3 time points (Days 28, 56, and 84) * All study injections will be administered using a TriGrid electroporation device |
| Cohort 3: Neoadjuvant chemotherapy alone | Active comparator | Procedure: Optional biopsy* Will be treated with standard of care neoadjuvant chemotherapy as determined by their treating physician * If archival tissue not sufficient, a research biopsy to obtain primary tissue must be done prior to day 28 * Subjects who begin neoadjuvant endocrine therapy but are determined to not be responding at the Day 14 biopsy may begin chemotherapy treatment, at the discretion of the treating physician. These subjects may be enrolled in cohort 3 |
| Cohort 4: Neoadjuvant chemotherapy + mammoglobin-A DNA vaccine | Experimental | Biological: Mammaglobin-A DNA Vaccine, Procedure: Optional biopsy* Will be treated with standard of care neoadjuvant chemotherapy as determined by their treating physician * If archival tissue not sufficient, a research biopsy to obtain primary tissue must be done prior to day 28 * Treated with 4 mg of mammaglobin-A DNA vaccine at 3 time points (Days 28, 56, and 84) * All study injections will be administered using a TriGrid electroporation device * Subjects who begin neoadjuvant endocrine therapy but are determined to not be responding at the Day 14 biopsy may begin chemotherapy treatment, at the discretion of the treating physician. These subjects may be enrolled in either cohort 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
- Newly diagnosed histologically confirmed invasive breast cancer.
- Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2- (0 or 1+ by IHC or FISH negative for amplification) breast cancer by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Patients with T1c tumors are eligible if they are considered candidates for neoadjuvant endocrine therapy or chemotherapy
- At least 1 measurable lesion.
- Candidate for neoadjuvant endocrine therapy or chemotherapy.
Key exclusion criteria (24 listed)
- A patient will be ineligible for inclusion in this study if ANY of the following criteria apply:
- Received any of the following for treatment of this cancer (except for the neoadjuvant endocrine therapy or chemotherapy specified within this protocol):
- Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days.
- Known metastatic disease.
- Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
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 |
|---|---|---|
| Mammaglobin-A DNA Vaccine | Biological | Cohort 2:Neoadjuvant endocrine + mammaglobin-A DNA vaccine, Cohort 4: Neoadjuvant chemotherapy + mammoglobin-A DNA vaccine |
| Optional biopsy | Procedure or surgery | Cohort 1:Neoadjuvant endocrine therapy alone, Cohort 2:Neoadjuvant endocrine + mammaglobin-A DNA vaccine, Cohort 3: Neoadjuvant chemotherapy alone, Cohort 4: Neoadjuvant chemotherapy + mammoglobin-A DNA vaccine |
Primary outcome
Safety as measured by the number of participants who experience an adverse event
Time frame: Day 126 (+/- 7days)
Assessment of plasmid DNA safety will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial. The following parameters will be assessed following vaccination: 1. Local signs and symptoms 2. Systemic signs and symptoms 3. Laboratory evaluations, including blood counts and serum chemistries 4. Adverse and serious adverse events Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0
3 secondary outcomes
Immune response
Time frame: Week 52
Progression-free survival (PFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
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 21 Apr 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
William Gillanders, M.D. principal investigator
Washington University School of Medicine
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 Mammaglobin-A DNA Vaccine and Optional biopsy in people with Breast Cancer and Breast Carcinoma, run by Washington University School of Medicine 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 18 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 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?
Safety as measured by the number of participants who experience an adverse event (time frame: Day 126 (+/- 7days)). 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 21 Apr 2026.