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NCT00866905 · ClinicalTrials.gov registry record · Phase 2
Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT00866905: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT00866905 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00866905, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.
Primary Outcome
Pathologic complete response (pCR) rate will be determined by the pathologic evaluation of breast and lymph node samples collected at the time of surgery. pCR is defined as no residual disease in breast or lymph nodes in resected tissue samples.
Interventions
- DRUG Cyclophosphamide
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2009-04 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT00866905 record still lists
NCT00866905 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT00866905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00866905 about?
NCT00866905 is a clinical study titled "Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer". We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or...
What is the current status of trial NCT00866905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2009-04. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00866905?
The interventions under investigation include: Cyclophosphamide (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00866905?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00866905's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 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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