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Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

NCT00309556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2011-12-30

No results posted yet for this study

Summary

Primarily, this clinical investigation compares the rates (percentages) of pathological complete remissions attained at the time of final surgery following 6 cycles each of epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2 positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2 negative disease).

Conditions

Interventions

DRUG

Epirubicin

6 cycles 75mg/m2 i.v. day 1 q3w

DRUG

Docetaxel

6 cycles 75mg/m2 i.v. day 1 q3w

DRUG

Capecitabine

6 cycles 1000mg/m2 oral, day 1-14 q2d

DRUG

Trastuzumab

cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Ebewe Pharma GmbH

    collaborator UNKNOWN

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Austrian Breast & Colorectal Cancer Study Group

    lead NETWORK

Principal Investigators

  • Guenther Steger, MD · Austrian Breast & Colorectal Cancer Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2009-11-30
Completion
2011-11-30

Countries

  • Austria

Study Locations

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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 NCT00309556 on ClinicalTrials.gov