Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia

Study Overview
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Brief Summary
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Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100. The investigators have therefore been performing a feasibility study to explore whether the integrated consent model involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.

Official Title
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A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2

Conditions
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Early Stage Breast Cancer

Intervention / Treatment
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* Drug: Ciprofloxacin
* Drug: Neupogen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary breast cancer Planned TC chemotherapy ≥19 years of age Able to provide verbal consent Exclusion Criteria: Contraindication to either Ciprofloxacin or G-CSF

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: Ciprofloxacin<br>Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC | Drug: Ciprofloxacin<br>* Antibiotic<br>|
| Active Comparator: G-CSF<br>Daily injection at home for the number of days as chosen by the treating physician | Drug: Neupogen<br>* Granulocyte-colony stimulating factor<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 hospital for treatment-related reasons | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy dose reduction | Number of participants who receive a dose reduction of their TC chemotherapy | 2 years | 
| Chemotherapy dose delay | Number of participants who receive a dose delay in their TC chemotherapy | 2 years | 
| Chemotherapy discontinuation | Number of participants who stop TC chemotherapy for any reason | 2 years | 
| Microbiologic infections | Number of participants who have a microbiologic infection (i.e: Clostridium difficile) | 2 years |