Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: GCSF administration on days 8 and 12 after chemotherapy

• Registration Number: NCT01658956
• Lead Sponsor: Jules Bordet Institute

Brief Summary

The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-05
• Last Update Posted: 2015-01-06
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 142

Inclusion Criteria

Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant

Exclusion Criteria

Eligibility to receive reimbursed GCSF

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcutaneous GCSF 5 µg/kg days 8 and 12	GCSF administration on days 8 and 12 after chemotherapy	Prophylactic administration of GCSF on days 8 and 12 following chemotherapy

Primary Outcome Measures

Name	Time	Method
Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU)	At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization

Secondary Outcome Measures

Name	Time	Method
Need for unplanned hospitalization	At the beginning of second chemotherapy cycle, no more than 30 days after randomization	Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration
Complicated febrile neutropenic episode	At the beginning of the second chemotherapy cycle, no more than 30 days after randomization	A complicated febrile neutropenic episode is defined as a febrile neutropenic episode (see above) that does not resolve without the occurrence of serious medical complication as defined in Klasterky J et al; JCO 2000 : 3038-3051
Mortality any cause	30 days from randomization

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium