# Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer

> **NCT00433420** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy** · enrollment: 2000 (estimated)

## Conditions studied

- Breast Cancer

## Interventions

- **BIOLOGICAL:** pegfilgrastim
- **DRUG:** cyclophosphamide
- **DRUG:** epirubicin hydrochloride
- **DRUG:** fluorouracil
- **DRUG:** paclitaxel
- **PROCEDURE:** adjuvant therapy

## Key facts

- **NCT ID:** NCT00433420
- **Lead sponsor:** IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2003-04
- **Primary completion:** 2006-05
- **Final completion:** 2027-12
- **Target enrollment:** 2000 (ESTIMATED)
- **Last updated:** 2026-04-30

## Collaborators

- Gruppo Italiano Mammella (GIM)

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00433420

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00433420, "Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT00433420. Licensed CC0.

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