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NCT00001250 · ClinicalTrials.gov registry record · Phase 2
Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT00001250: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00001250 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001250, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Patients are prospectively randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin, leucovorin, cytoxan, granuloctye-colony stimulating factor \[FLAC/G-CSF\]) chemotherapy either before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate reconstruction for mastectomy is acceptable. Upon completion of local therapy and chemotherapy in either treatment group, all estrogen receptor positive patients receive tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone scan, chest x-ray and blood work are performed yearly.
Interventions
- DRUG preoperative dose intense chemotherapy (FLAC/G-CSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 1989-12 |
| Est. Completion | 2002-10 |
| Phase | Phase 2 |
What the finished NCT00001250 record still lists
NCT00001250 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which preoperative dose intense chemotherapy (FLAC/G-CSF) is the first listed.
NCT00001250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001250 about?
NCT00001250 is a clinical study titled "Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial". Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Patients are prospectively randomized to receive five ...
What is the current status of trial NCT00001250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 1989-12. Estimated completion is 2002-10.
What interventions are being tested in trial NCT00001250?
The interventions under investigation include: preoperative dose intense chemotherapy (FLAC/G-CSF) (DRUG).
Who is sponsoring clinical trial NCT00001250?
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 NCT00001250's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 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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