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NCT00001498 · ClinicalTrials.gov registry record · Phase 2
A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction, High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support, and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00001498: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00001498 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001498, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
Stage III patients may begin therapy prior to or following surgery. Patients with undrainable significant third space fluid collection (e.g., pleural effusions, ascites) are entered directly on Consolidation. Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks for 4 courses. Patients then receive two 3-week courses of consolidation therapy with cyclophosphamide, followed by daily granulocyte colony-stimulating factor until completion of leukapheresis. Patients next receive myeloablative doses of thiotepa followed by stem cell rescue and granulocyte colony-stimulating factor. After hematopoietic reconstitution, patients receive 24-hour infusions of paclitaxel every 3 weeks for 4 doses, followed by doxorubicin or vinblastine every 3 weeks for 4 doses. Patients are then evaluated for additional therapy (surgery, radiotherapy, or hormonal therapy) as appropriate. Patients are followed every 3 months for 1 year, then every 6 months.
Interventions
- DRUG 5-fluorouracil
- DRUG cyclophosphamide
- DRUG leucovorin
- DRUG methotrexate
- PROCEDURE peripheral blood progenitor cell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 1996-02 |
| Est. Completion | 2000-12 |
| Phase | Phase 2 |
What the finished NCT00001498 record still lists
NCT00001498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which 5-fluorouracil is the first listed.
NCT00001498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001498 about?
NCT00001498 is a clinical study titled "A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction, High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support, and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Cancer". Stage III patients may begin therapy prior to or following surgery. Patients with undrainable significant third space fluid collection (e.g., pleural effusions, ascites) are entered directly on Consolidation. Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks f...
What is the current status of trial NCT00001498?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 1996-02. Estimated completion is 2000-12.
What interventions are being tested in trial NCT00001498?
The interventions under investigation include: 5-fluorouracil (DRUG), cyclophosphamide (DRUG), leucovorin (DRUG), methotrexate (DRUG), peripheral blood progenitor cell (PROCEDURE).
Who is sponsoring clinical trial NCT00001498?
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 NCT00001498's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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