G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Chemotherapeutic Agent Toxicity; Neutropenia
• Interventions: Biological: filgrastim

• Registration Number: NCT00771433
• Lead Sponsor: Centre Francois Baclesse

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Status Verified: 2008-12
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	filgrastim	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	filgrastim	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of febrile neutropenia

Trial Locations

Locations (1)

Centre Regional Francois Baclesse; 🇫🇷 Caen, France