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Mammaglobin-A DNA Vaccine for Breast Cancer
Phase 1
Waitlist Available
Led By William Gillanders, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Postmenopausal or premenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing if it's safe to inject a gene into people with breast cancer, in order to create an immune response to the cancer cells.
Who is the study for?
This trial is for postmenopausal or premenopausal breast cancer patients aged 18+, with ER+ and HER2- tumors aiming for surgery. They must have a measurable lesion expressing mammaglobin-A, be responding to neoadjuvant therapy, and have good organ function. Exclusions include pregnancy, known metastasis, recent investigational drugs use, vaccine allergies, uncontrolled illnesses, HIV-positive status, high non-adherence risk or obscured injection sites.Check my eligibility
What is being tested?
The study tests the safety and immune response of a Mammaglobin-A DNA Vaccine in breast cancer patients undergoing endocrine therapy before surgery. The vaccine contains mammaglobin-A gene DNA which may help the immune system fight cancer cells by recognizing them more effectively.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to vaccines such as local site reactions (redness or swelling), general symptoms like fever or fatigue due to an immune response activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am either postmenopausal or premenopausal.
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I have been recently diagnosed with invasive breast cancer.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety as measured by the number of participants who experience an adverse event
Secondary outcome measures
Immune response
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Objective tumor response rate (ORR)
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 4: Neoadjuvant chemotherapy + mammoglobin-A DNA vaccineExperimental Treatment2 Interventions
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
Group II: Cohort 2:Neoadjuvant endocrine + mammaglobin-A DNA vaccineExperimental Treatment2 Interventions
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
Group III: Cohort 1:Neoadjuvant endocrine therapy aloneActive Control1 Intervention
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
Group IV: Cohort 3: Neoadjuvant chemotherapy aloneActive Control1 Intervention
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
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,940 Previous Clinical Trials
2,303,368 Total Patients Enrolled
46 Trials studying Breast Cancer
5,141 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
865 Previous Clinical Trials
327,672 Total Patients Enrolled
37 Trials studying Breast Cancer
103,439 Patients Enrolled for Breast Cancer
Rising Tide FoundationOTHER
13 Previous Clinical Trials
4,242 Total Patients Enrolled
1 Trials studying Breast Cancer
26 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I have had a biopsy of lymph nodes in my armpit.The thickness of the skin and tissue at the injection sites is too large.I am managing an autoimmune disease with immunosuppressive drugs.I have a metal implant in the skin or muscle near my shoulder.I do not have significant blood, lung, heart, liver, or kidney problems.My breast cancer is ER+ and HER2-, aiming for surgery to remove the tumor and affected lymph nodes.My organs and bone marrow are working well.My doctor thinks my treatment before surgery is working, or my tumor growth rate is low.You are currently using any electronic stimulation device.I haven't received cancer treatments outside of those specified in this study.I do not have any uncontrolled illnesses.You are likely to not follow the study guidelines.I am HIV-positive.I am 18 years old or older.I am either postmenopausal or premenopausal.You have fainted within the past year.You have any ongoing or recurring neurological condition, except for having had one fever-related seizure as a child.I am eligible for hormone or chemotherapy before surgery.I have been recently diagnosed with invasive breast cancer.You have at least one specific area of disease that can be measured.The primary tumor must show a certain protein called mammaglobin-A when tested.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1:Neoadjuvant endocrine therapy alone
- Group 2: Cohort 2:Neoadjuvant endocrine + mammaglobin-A DNA vaccine
- Group 3: Cohort 3: Neoadjuvant chemotherapy alone
- Group 4: Cohort 4: Neoadjuvant chemotherapy + mammoglobin-A DNA vaccine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open spots left for enrollment in this trial?
"This clinical trial is actively trying to enlist volunteers, as evidenced by the information listed on clinicaltrials.gov. The original posting was made on July 1st 2015 and it has been recently updated (January 26th 2022)."
Answered by AI
How many participants are currently included in this empirical investigation?
"Affirmative. Information on clinicaltrials.gov points to this trial as currently recruiting participants, commencing with its original posting date of July 1st 2015 and most recent update occurring January 26th 2022. The study is searching for 56 volunteers across two sites."
Answered by AI
How secure is Optional biopsy for patient's well-being?
"We have assessed Optional biopsy's safety as a 1 due to the limited data pointing towards its efficacy that is found in Phase 1 clinical trials."
Answered by AI
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