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NCT00088985 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT00088985: Clinical Trial Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00088985 is a Phase 2 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088985, a Phase 2 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic breast cancer.
Primary Outcome
Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response) Complete Response (CR)- Disappearance of all target lesions Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter.
Interventions
- BIOLOGICAL trastuzumab
- DRUG vinorelbine ditartrate
- BIOLOGICAL therapeutic autologous dendritic cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2004-01 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
Why NCT00088985 stopped before completion
NCT00088985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which trastuzumab is the first listed.
NCT00088985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00088985 about?
NCT00088985 is a clinical study titled "Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer". RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as vinorelbine, work in...
What is the current status of trial NCT00088985?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2004-01. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00088985?
The interventions under investigation include: trastuzumab (BIOLOGICAL), vinorelbine ditartrate (DRUG), therapeutic autologous dendritic cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00088985?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00088985's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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