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NCT00004067 · ClinicalTrials.gov registry record · Phase 3
Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2
A Phase 3 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,130
- Enrollment target
NCT00004067: Completed Phase 3 study, sponsored by NSABP Foundation.
NCT00004067 is a Phase 3 study that has completed, run by NSABP Foundation. The registered enrollment target is 2,130 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (176% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004067, a Phase 3 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,130 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use 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. It is not yet known whether combination chemotherapy plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer. PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.
Primary Outcome
Breast cancer recurrence, second primary cancer, death from any cause as first event
Interventions
- DRUG cyclophosphamide
- DRUG adriamycin
- BIOLOGICAL herceptin
- DRUG taxol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,130 participants |
| Start Date | 2000-02 |
| Est. Completion | 2019-11 |
| Phase | Phase 3 |
What the finished NCT00004067 record still lists
NCT00004067 is an interventional study that assigns participants to a tested intervention. Its 2,130 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (176% higher).
The record links to 0 conditions, and to 4 interventions - of which cyclophosphamide is the first listed.
NCT00004067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004067 about?
NCT00004067 is a clinical study titled "Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2". RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use 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...
What is the current status of trial NCT00004067?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,130 participants. The study started on 2000-02. Estimated completion is 2019-11.
What interventions are being tested in trial NCT00004067?
The interventions under investigation include: cyclophosphamide (DRUG), adriamycin (DRUG), herceptin (BIOLOGICAL), taxol (DRUG).
Who is sponsoring clinical trial NCT00004067?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004067's enrollment target sits among peer trials
2,130 97th of 2000 higher than 1,903 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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