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NCT00429104 · ClinicalTrials.gov registry record · Phase 2
Herceptin and GM-CSF for Metastatic Breast Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00429104: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00429104 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00429104, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To determine the patient's tumor response rate that this protocol will produce. 2. To determine the 1 year progression-free survival that this protocol will produce. Secondary Objective: 1\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF).
Primary Outcome
Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.
Interventions
- DRUG GM-CSF
- DRUG Herceptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2002-08 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00429104 record still lists
NCT00429104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which GM-CSF is the first listed.
NCT00429104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00429104 about?
NCT00429104 is a clinical study titled "Herceptin and GM-CSF for Metastatic Breast Cancer". Primary Objectives: 1. To determine the patient's tumor response rate that this protocol will produce. 2. To determine the 1 year progression-free survival that this protocol will produce. Secondary Objective: 1\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the me...
What is the current status of trial NCT00429104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2002-08. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00429104?
The interventions under investigation include: GM-CSF (DRUG), Herceptin (DRUG).
Who is sponsoring clinical trial NCT00429104?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00429104's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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