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Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

NCT00021255 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3222

Last updated 2016-11-15

Study results available
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Summary

Primary objective:

* Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

Secondary objective:

* Compare overall survival of participants treated with these regimens.
* Compare the toxic effects (including cardiac) of these regimens in these participants.
* Compare quality of life of participants treated with these regimens.
* Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants.
* For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Docetaxel

DRUG

Herceptin

DRUG

Carboplatin

Sponsors & Collaborators

  • Cancer International Research Group (CIRG)

    collaborator OTHER

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • AUSSEL Jean Philippe · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • Egypt
  • Estonia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Lebanon
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom
  • Uruguay
  • Venezuela

Study Locations

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Entities

Drugs
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 NCT00021255 on ClinicalTrials.gov