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NCT00005970 · ClinicalTrials.gov registry record · Phase 3
Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 3,436
- Enrollment target
NCT00005970: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00005970 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 3,436 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (345% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005970, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,436 participants
- Enrollment target
Study Summary
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread to the lymph nodes or high-risk and has not spread to the lymph nodes. Drugs used in chemotherapy 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 is more effective with or without trastuzumab in treating breast cancer.
Primary Outcome
Will be estimated using the Kaplan-Meier method. A stratified log-rank test will be used to assess whether DFS differs with respect to the addition of trastuzumab to a chemotherapy regimen including AC and paclitaxel. Ninety-five percent confidence intervals will be reported for relative risks, for DFS at the 5-year point, and for absolute benefit as defined by differences in DFS and OS.
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- DRUG Doxorubicin Hydrochloride
- DRUG Aromatase Inhibition Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,436 participants |
| Start Date | 2000-05-19 |
| Est. Completion | 2010-01-27 |
| Phase | Phase 3 |
What the finished NCT00005970 record still lists
NCT00005970 is an interventional study that assigns participants to a tested intervention. Its 3,436 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 (345% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00005970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005970 about?
NCT00005970 is a clinical study titled "Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer". This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive and has spread t...
What is the current status of trial NCT00005970?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,436 participants. The study started on 2000-05-19. Estimated completion is 2010-01-27.
What interventions are being tested in trial NCT00005970?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Doxorubicin Hydrochloride (DRUG), Aromatase Inhibition Therapy (DRUG).
Who is sponsoring clinical trial NCT00005970?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005970's enrollment target sits among peer trials
3,436 70th of 2000 higher than 1,931 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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