A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia

Study Overview
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Brief Summary
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In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to which administration schedule of Neupogen is the best for patients, the investigators are performing a randomized study for which patients will receive either 5, 7 or 10 days of Neupogen. Neupogen can cost approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment, this can cost $16,000 compared to a 5 day treatment which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high cost. This study will use an oral consent model to compare 5, 7 and 10 days of Neupogen to evaluate rates of febrile neutropenia and hospitalization.

Official Title
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A Multi Centre Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (REaCT-G2)

Conditions
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Early Stage Breast Cancer

Intervention / Treatment
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* Drug: Neupogen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary breast cancer Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy ≥19 years of age Able to provide verbal consent Exclusion Criteria: Contraindication to Filgrastim

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neupogen for 5 days<br>Neupogen injection for 5 days | Drug: Neupogen<br>* Subcutaneous injections<br>* Other names: Filgrastim;|
| Active Comparator: Neupogen for 7 days<br>Neupogen injection for 7 days | Drug: Neupogen<br>* Subcutaneous injections<br>* Other names: Filgrastim;|
| Active Comparator: Neupogen for 10 days<br>Neupogen injection for 10 days | Drug: Neupogen<br>* Subcutaneous injections<br>* Other names: Filgrastim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Febrile neutropenia | Number of participants with febrile neutropenia | 2 years | 
| Treatment-related hospitalization | Number of participants admitted to emergency for treatment-related reasons | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy dose delay | Number of participants who experience a dose delay with their chemotherapy treatment | 2 years | 
| Chemotherapy dose reduction | Number of participants who experience a dose reduction in their chemotherapy treatment | 2 years | 
| Chemotherapy discontinuation | Number of participants who stop chemotherapy for any reason | 2 years |