# A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer

> **NCT00001338** · PHASE3 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 65 (—)

## Conditions studied

- Breast Neoplasms
- Fever
- Hematologic Diseases
- Neutropenia
- Sepsis

## Interventions

- **DRUG:** FLAC chemotherapy with GM-CSF

## Key facts

- **NCT ID:** NCT00001338
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 1993-06
- **Primary completion:** —
- **Final completion:** 2001-01
- **Target enrollment:** 65 (—)
- **Last updated:** 2008-03-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00001338

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00001338, "A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer". Retrieved via AI Analytics 2026-07-30 from https://api.ai-analytics.org/clinical/NCT00001338. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
