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NCT00542451 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 406
- Enrollment target
NCT00542451: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00542451 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 406 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (205% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00542451, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 406 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative disease. This tests utilizes a well tolerated regimen of weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2 positive. We would like to determine how effective this drug combination is when used in women with early stage breast cancer, as well as to better define the side effects of this treatment.
Primary Outcome
Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2007-10 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 2 |
What the finished NCT00542451 record still lists
NCT00542451 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (205% higher).
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT00542451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00542451 about?
NCT00542451 is a clinical study titled "Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer". The purpose of this study is to find out what effect the postoperative combination of therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node positive and high risk node negative d...
What is the current status of trial NCT00542451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 406 participants. The study started on 2007-10. Estimated completion is 2022-08-30.
What interventions are being tested in trial NCT00542451?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00542451?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00542451's enrollment target sits among peer trials
406 94th of 2000 higher than 1,906 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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