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

Brief 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

COMPLETED

phase

PHASE3

study type

INTERVENTIONAL

enrollment

1856

sponsor

European Organisation for Research and Treatment of Cancer - EORTC

conditions

Breast Cancer

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

start date

2001-03-01

primary completion date

2006-11-01

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters