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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 is a Phase 3 study that has completed, run by NSABP Foundation. The registered enrollment target is 2,130 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004067
The ClinicalTrials.gov registry entry for NCT00004067 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which cyclophosphamide is the first listed.
NCT00004067 reports 0 study locations.
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.
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