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NCT00343512 · ClinicalTrials.gov registry record · Phase 2
Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00343512: Clinical Trial Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT00343512 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00343512, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).
Primary Outcome
whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)
Interventions
- GENETIC protein expression analysis
- OTHER laboratory biomarker analysis
- PROCEDURE biopsy
- DRUG docetaxel
- PROCEDURE conventional surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2004-02 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
Why NCT00343512 stopped before completion
NCT00343512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 5 interventions - of which protein expression analysis is the first listed.
NCT00343512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00343512 about?
NCT00343512 is a clinical study titled "Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer". RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinic...
What is the current status of trial NCT00343512?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2004-02. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00343512?
The interventions under investigation include: protein expression analysis (GENETIC), laboratory biomarker analysis (OTHER), biopsy (PROCEDURE), docetaxel (DRUG), conventional surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00343512?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00343512's enrollment target sits among peer trials
34 1539th of 2000 higher than 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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