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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

NCT00455533 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2016-02-24

Study results available
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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

Interventions

DRUG

Ixabepilone

Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks

DRUG

Paclitaxel

Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks

DRUG

Cyclophosphamide

Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks

DRUG

Doxorubicin

Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Argentina
  • Austria
  • France
  • Germany
  • India
  • Italy
  • Peru
  • Philippines
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00455533 on ClinicalTrials.gov