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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 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 34 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00343512
The ClinicalTrials.gov registry entry for NCT00343512 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which protein expression analysis is the first listed.
NCT00343512 reports 0 study locations.
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.
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