# 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** · PHASE3 · COMPLETED · sponsor: **European Organisation for Research and Treatment of Cancer - EORTC** · enrollment: 1856 (actual)

## Conditions studied

- 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
- **PROCEDURE:** neoadjuvant therapy
- **RADIATION:** radiation therapy

## Key facts

- **NCT ID:** NCT00017095
- **Lead sponsor:** European Organisation for Research and Treatment of Cancer - EORTC
- **Sponsor class:** NETWORK
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2001-03
- **Primary completion:** 2006-11
- **Final completion:** —
- **Target enrollment:** 1856 (ACTUAL)
- **Last updated:** 2013-10-24

## Collaborators

- [object Object]
- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00017095

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00017095, "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". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT00017095. Licensed CC0.

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