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COMPLETED Phase 2

A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer

NCT00879086 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 104 participants
Start Date 2009-03-31
Est. Completion 2014-04-30
Phase Phase 2

Sponsor

Eisai

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00879086

The ClinicalTrials.gov registry entry for NCT00879086 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00879086 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00879086?

The interventions under investigation include: Ixabepilone (DRUG), Eribulin Mesylate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00879086?

This trial is sponsored by Eisai, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial