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NCT00082641 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
A Phase 1 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00082641: Completed Phase 1 study, sponsored by University of Nebraska.
NCT00082641 is a Phase 1 study that has completed, run by University of Nebraska. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00082641, a Phase 1 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or after chemotherapy and radiation therapy may cause a stronger immune response. PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53.
Primary Outcome
This outcome measure looks at the safety of the vaccine by documenting the number of grade 2, 3, or toxicities experienced by participants related to the vaccine.
Interventions
- BIOLOGICAL autologous dendritic cell-adenovirus p53 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-01-01 |
| Est. Completion | 2018-01-01 |
| Phase | Phase 1 |
What the finished NCT00082641 record still lists
NCT00082641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which autologous dendritic cell-adenovirus p53 vaccine is the first listed.
NCT00082641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00082641 about?
NCT00082641 is a clinical study titled "Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer". RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to da...
What is the current status of trial NCT00082641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2004-01-01. Estimated completion is 2018-01-01.
What interventions are being tested in trial NCT00082641?
The interventions under investigation include: autologous dendritic cell-adenovirus p53 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00082641?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00082641's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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