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NCT00636441 · ClinicalTrials.gov registry record · Phase 2
Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT00636441 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 56 participants.
The verdict
NCT00636441, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer patients to receive preoperative systemic chemotherapy in either a "genomic-guided" arm or a "non-guided arm." The "genomic-guided" method (Arm 1) used genomic expression profiling to assign the preoperative therapy (Doxorubicin/Cyclophosphamide (AC) versus Docetaxel/Cyclophosphamide (TC), while Arm 2 used random assignment to these two therapies.
Interventions
- DRUG Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00636441
The ClinicalTrials.gov registry entry for NCT00636441 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC) is the first listed.
NCT00636441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00636441 about?
NCT00636441 is a clinical study titled "Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer". This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer patients to receive preoperative systemic chemotherapy in either a "genomic-guided" arm or a "non-guided arm." The "genomic-guided" method (Arm 1) used genomic expression profiling to assign the preoperative...
What is the current status of trial NCT00636441?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2008-04. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00636441?
The interventions under investigation include: Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC) (DRUG).
Who is sponsoring clinical trial NCT00636441?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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