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Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer

NCT00630032 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 762

Last updated 2024-02-21

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.

Conditions

Interventions

DRUG

cyclophosphamide

500 mg/m² every 3 weeks

DRUG

Docetaxel

100 mg/m² every 3 weeks

DRUG

epirubicin hydrochloride

100 mg/m² every 3 weeks

DRUG

fluorouracil

500 mg/m² every 3 weeks

DRUG

ixabepilone

40 mg/m² every 3 weeks

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Mario Campone, MD · ICO Centre Regional Rene Gauducheau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2017-06-30
Completion
2020-09-03

Countries

  • United States
  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00630032 on ClinicalTrials.gov