---
title: G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
nct_id: NCT00771433
overall_status: COMPLETED
phase: PHASE2
sponsor: Centre Francois Baclesse
study_type: INTERVENTIONAL
primary_condition: Breast Cancer
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00771433.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00771433"
ct_last_update_post_date: 2011-05-13
last_seen_at: "2026-05-12T06:42:23.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer

**Official Title:** Evaluation of the Efficacy of Adding Daily G-CSF (Granulocyte Colony Stimulating Factor) for Prevention of Hematologic Toxicity Due to Neoadjuvant or Adjvuant Chemotherapy in Breast Cancer

**NCT ID:** [NCT00771433](https://clinicaltrials.gov/study/NCT00771433)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Centre Francois Baclesse
- **Conditions:** Breast Cancer, Chemotherapeutic Agent Toxicity, Neutropenia
- **Start Date:** 2007-10
- **CT.gov Last Update:** 2011-05-13

## Brief Summary

RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing neutropenia.

PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in women receiving chemotherapy for breast cancer.

## Detailed Description

OBJECTIVES:

Primary

* Evaluate the efficacy of filgrastim (G-CSF) in preventing hematological toxicity in women with breast cancer receiving neoadjuvant or adjuvant chemotherapy.

Secondary

* Compare actual vs theoretical dose intensity.

OUTLINE: This is a multicenter study. Patients are stratified according to age (\< 65 years vs ≥ 65 years) and prior chemotherapy (adjuvant vs neoadjuvant). Patients are assigned to 1 of 2 groups.

* Group 1: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.
* Group 2: Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:

  * Six courses of epirubicin hydrochloride and docetaxel
  * Six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC) 100 or 3 courses of FEC 100 and 3 courses of docetaxel 100
* Must have received at least 2 chemotherapy regimens prior to study therapy
* No malignant hematological disease
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No contraindications to standard neoadjuvant or adjuvant chemotherapy
* No known hypersensitivity to G-CSF or any of its components
* No patients deprived of liberty or under guardianship
* No psychological, familial, social, or geographical reasons preventing follow-up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent participation in another experimental drug study
```

## Arms

- **Group 1** (EXPERIMENTAL) — Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.
- **Group 2** (EXPERIMENTAL) — Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.

## Interventions

- **filgrastim** (BIOLOGICAL) — Given subcutaneously

## Primary Outcomes

- **Occurrence of febrile neutropenia**

## Locations (1)

- Centre Regional Francois Baclesse, Caen, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre regional francois baclesse|caen||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00771433.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00771433*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*