# 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

Clinical trial · European Organisation for Research and Treatment of Cancer - EORTC

- Archive id: nct:NCT00017095
- Published: 2003-01-27
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT00017095
- Source URL: https://clinicaltrials.gov/study/NCT00017095
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under 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._

## 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

Topics: [Gene & Cell Therapy](https://space-kitty.com/topics/gene-cell-therapy)

---
Space Kitty Archive · https://space-kitty.com · API: https://space-kitty.com/api/v1 · MCP: https://space-kitty.com/mcp · Premium: $0.20/request via x402 (Base Sepolia (testnet)). Metadata: arXiv (CC0), OpenAlex (CC0), Europe PMC (CC BY/CC0 works), ClinicalTrials.gov.