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NCT02204098 · ClinicalTrials.gov registry record · Phase 1
Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy
A Phase 1 study of Breast Cancer and Breast Carcinoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT02204098: Active Phase 1 study of Breast Cancer and Breast Carcinoma, sponsored by Washington University School of Medicine.
NCT02204098 is a Phase 1 study of Breast Cancer and Breast Carcinoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02204098, a Phase 1 study of Breast Cancer and Breast Carcinoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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 a
Conditions Studied
Interventions
- BIOLOGICAL Mammaglobin-A DNA Vaccine
- PROCEDURE Optional biopsy
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-01-07 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 1 |
What the registry record for NCT02204098 still lists
NCT02204098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Mammaglobin-A DNA Vaccine is the first listed.
NCT02204098 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT02204098 about?
NCT02204098 is a clinical study titled "Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy". 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 breas...
What is the current status of trial NCT02204098?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-01-07. Estimated completion is 2028-08-31.
What conditions does trial NCT02204098 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Carcinoma, Malignant Neoplasm of Breast.
What interventions are being tested in trial NCT02204098?
The interventions under investigation include: Mammaglobin-A DNA Vaccine (BIOLOGICAL), Optional biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02204098?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02204098 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02204098's enrollment target sits among peer trials
27 1019th of 1224 higher than 198 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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