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NCT00879086 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT00879086: Completed Phase 2 study of Breast Cancer, sponsored by Eisai.
NCT00879086 is a Phase 2 study of Breast Cancer that has completed, run by Eisai. The registered enrollment target is 104 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879086, a Phase 2 study of Breast Cancer, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.
Primary Outcome
Neuropathy AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and coded according to the current version of the Medical Dictionary for Regulatory Activities (MedDRA). Neuropathy AEs included the broad list of preferred terms (PTs) defined in the Standard MedDRA Query for Neuropathy and the following additional PTs: neuropathy, hyperesthesia, painful response to normal stimuli, pallanesthesia, and allodynia. If the post-ba
Conditions Studied
Interventions
- DRUG Ixabepilone
- DRUG Eribulin Mesylate
Study Locations (20)
Florida
- Comprehensive Cancer Care Specialist of Boca - Boca Raton
- Robert R. Carroll, MD, PA - Gainesville
- Hematology Oncology Associates - Lake Worth
- Medical Specialists of the Palm Beaches - Lake Worth
- Ocala Oncology Center - Ocala
- Hematology Oncology Associates of Treasure Coast - Port Saint Lucie
- Oncology and Hematology Associates of West Broward - Tamarac
California
- Healing Hands Oncology and Medical Care - Hawthorne
- University of Southern California - Los Angeles
- Comprehensive Cancer Center - Palm Springs
Louisiana
- Hematology and Oncology Specialists - Marrero
- Metairie Institute of Comprehensive Health - Metairie
- Hematology and Oncology Specialists - New Orleans
Illinois
- Hematology Oncology Associates of Illinois - Chicago
- Decatur Memorial Hospital - Decatur
Maryland
- Maryland Oncology Hematology, PA - Columbia
- Washington County Hospital - Hagerstown
Arizona
- Northern AZ Hematology and Oncology Associates - Sedona
Indiana
- Central Indiana Cancer Centers - Indianapolis
Iowa
- Heartland Oncology Hematology - Council Bluffs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2009-03-31 |
| Est. Completion | 2014-04-30 |
| Phase | Phase 2 |
What the finished NCT00879086 record still lists
NCT00879086 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ixabepilone is the first listed.
NCT00879086 names 20 study sites across 8 states, led by Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT00879086 about?
NCT00879086 is a clinical study titled "A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer". The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) gr...
What is the current status of trial NCT00879086?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2009-03-31. Estimated completion is 2014-04-30.
What conditions does trial NCT00879086 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00879086?
The interventions under investigation include: Ixabepilone (DRUG), Eribulin Mesylate (DRUG).
Who is sponsoring clinical trial NCT00879086?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00879086 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00879086's enrollment target sits among peer trials
104 553rd of 1224 higher than 669 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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