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Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer

NCT00017095 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1856

Last updated 2013-10-24

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.

PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.

Conditions

Interventions

BIOLOGICAL

filgrastim

DRUG

cyclophosphamide

DRUG

docetaxel

DRUG

epirubicin hydrochloride

DRUG

fluorouracil

GENETIC

microarray analysis

OTHER

immunohistochemistry staining method

OTHER

laboratory biomarker analysis

PROCEDURE

biopsy

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

RADIATION

radiation therapy

Sponsors & Collaborators

  • Swedish Breast Cancer Group

    collaborator OTHER

  • Swiss Cancer Institute

    collaborator OTHER

  • Anglo Celtic Cooperative Oncology Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Herve Bonnefoi · Institut Bergonie, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2006-11-30

Countries

  • Belgium
  • France
  • Netherlands
  • Poland
  • Portugal
  • Slovenia
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT00017095 on ClinicalTrials.gov