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NCT00455533 · ClinicalTrials.gov registry record · Phase 2

Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer

A Phase 2 study of Breast Cancer, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
384
Enrollment target
20
Study locations

NCT00455533 is a Phase 2 study of Breast Cancer that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 384 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00455533, a Phase 2 study of Breast Cancer, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
384 participants
Enrollment target
20
Study locations

Study Summary

The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Cyclophosphamide
  • DRUG Doxorubicin
  • DRUG Paclitaxel
  • DRUG Ixabepilone

Study Locations (20)

Other

  • Local Institution - Salzburg
  • Local Institution - Vienna
  • Local Institution - Bordeaux
  • Local Institution - Saint-Herblain
  • Local Institution - Düsseldorf
  • Local Institution - Erlangen

Florida

  • Northwest Oncology & Hematology Associates - Coral Spring
  • Florida Cancer Research Institute - Davie
  • Medical Specialists Of Palm Beaches - Lake Worth
  • Moffitt Cancer Center - Tampa

Buenos Aires

  • Local Institution - Buenos Aires
  • Local Institution - Buenos Aires
  • Local Institution - Capital Federal
  • Local Institution - Capital Federal

Washington

  • Virginia Mason Medical Center - Seattle
  • Providence Cancer Center - Spokane

California

  • Comprehensive Cancer Center - Palm Springs

Kentucky

  • University Medical Center, Inc - Louisville

New Mexico

  • University Of New Mexico Cancer Center - Albuquerque

New York

  • Albert Einstein Cancer Center - The Bronx

Trial Details

FieldValue
Enrollment Target 384 participants
Start Date 2007-10
Est. Completion 2009-12
Phase Phase 2

Sponsor

Bristol-Myers Squibb

1,025 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00455533

The ClinicalTrials.gov registry entry for NCT00455533 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT00455533 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Buenos Aires.

Frequently Asked Questions

What is clinical trial NCT00455533 about?

NCT00455533 is a clinical study titled "Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer". The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomark...

What is the current status of trial NCT00455533?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 384 participants. The study started on 2007-10. Estimated completion is 2009-12.

What conditions does trial NCT00455533 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00455533?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Ixabepilone (DRUG).

Who is sponsoring clinical trial NCT00455533?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00455533 being conducted?

This trial has 20 study locations across California, Florida, Kentucky, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.