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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: Completed Phase 1 study, sponsored by Baylor Research Institute.
NCT02018458 is a Phase 1 study that has completed, run by Baylor Research Institute. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 . This will include all patients (eligible and ineligible) who receive at least 1 inoculation of DC vaccine therapy. This safety population will also be used for the summaries and analysis of all safety parameters (drug exposure, tables of adverse events information, including serious adverse events, etc.).
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 |
What the finished NCT02018458 record still lists
NCT02018458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which LA TNBC: DC vaccine+Preop chemo is the first listed.
NCT02018458 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02018458's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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