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NCT02018458 · ClinicalTrials.gov registry record · Phase 1
Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer
A Phase 1 study, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02018458 is a Phase 1 study that has completed, run by Baylor Research Institute. The registered enrollment target is 10 participants.
The verdict
NCT02018458, a Phase 1 study, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the safety and feasibility of combining cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy. The secondary objectives of this trial are to determine pathologic complete response rates; disease-free survival; to assess immune biomarkers of immunity (antigen-specific CD8+ T cell immunity and TH2 T cells) in breast cancer biopsy specimens and blood samples in patients receiving DC vaccinations; and to assess the feasibility of immunizing LA TNBC and ER+/HER2- BC patients with patient-specific tumor antigens.
Interventions
- BIOLOGICAL LA TNBC: DC vaccine+Preop chemo
- BIOLOGICAL ER+/HER2-BC:DC vaccine+Preop chemo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-05 |
| Est. Completion | 2019-09-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02018458
The ClinicalTrials.gov registry entry for NCT02018458 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor Research Institute, which has 180 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LA TNBC: DC vaccine+Preop chemo is the first listed.
NCT02018458 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02018458 about?
NCT02018458 is a clinical study titled "Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer". The primary objective of this study is to determine the safety and feasibility of combining cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy. The secondary objectives of this trial are to determine pathologic complete response rates; disease-free survival; to assess...
What is the current status of trial NCT02018458?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2019-09-18.
What interventions are being tested in trial NCT02018458?
The interventions under investigation include: LA TNBC: DC vaccine+Preop chemo (BIOLOGICAL), ER+/HER2-BC:DC vaccine+Preop chemo (BIOLOGICAL).
Who is sponsoring clinical trial NCT02018458?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
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