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Docetaxel in Breast Cancer

NCT00312208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3299

Last updated 2013-12-30

Study results available
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Summary

Primary objective :

* To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.

Secondary objectives :

* To compare toxicity and quality of life between the 2 above-mentioned arms.
* To evaluate pathologic and molecular markers for predicting efficacy.

Conditions

Interventions

DRUG

docetaxel, doxorubicin, cyclophosphamide

TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.

DRUG

Docetaxel,doxorubicin, cyclophosphamide

AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.

Sponsors & Collaborators

  • Cancer International Research Group (CIRG)

    collaborator OTHER

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Jean-Philippe AUSSEL · 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
2001-11-30
Primary Completion
2008-10-31
Completion
2013-10-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Croatia
  • Cyprus
  • Czechia
  • Egypt
  • Estonia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Lebanon
  • Mexico
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • Saudi Arabia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Uruguay
  • Venezuela

Study Locations

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Entities

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 NCT00312208 on ClinicalTrials.gov