Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00093808 · ClinicalTrials.gov registry record · Phase 2
Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT00093808: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00093808 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00093808, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Giving capecitabine and vinorelbine together with trastuzumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine and vinorelbine together with trastuzumab works in treating patients who have metastatic breast cancer.
Primary Outcome
A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total num
Interventions
- DRUG capecitabine
- BIOLOGICAL trastuzumab
- DRUG vinorelbine tartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2004-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT00093808 record still lists
NCT00093808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which capecitabine is the first listed.
NCT00093808 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00093808 about?
NCT00093808 is a clinical study titled "Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as capecitabine and vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor killing substances to them without...
What is the current status of trial NCT00093808?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2004-08. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00093808?
The interventions under investigation include: capecitabine (DRUG), trastuzumab (BIOLOGICAL), vinorelbine tartrate (DRUG).
Who is sponsoring clinical trial NCT00093808?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00093808's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03313011 · 47 participants
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
- NCT03467516 · 47 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
- NCT03886662 · 47 participants · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
- NCT04013802 · 47 participants · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia