Skip to main content
Clinical Trials/NCT02816164
NCT02816164
Completed
Phase 4

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)

Ottawa Hospital Research Institute1 site in 1 country324 target enrollmentSeptember 2016
InterventionsNeupogen

Overview

Phase
Phase 4
Intervention
Neupogen
Conditions
Early Stage Breast Cancer
Sponsor
Ottawa Hospital Research Institute
Enrollment
324
Locations
1
Primary Endpoint
Febrile neutropenia
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
February 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Neupogen for 5 days

Neupogen injection for 5 days

Intervention: Neupogen

Neupogen for 7 days

Neupogen injection for 7 days

Intervention: Neupogen

Neupogen for 10 days

Neupogen injection for 10 days

Intervention: Neupogen

Outcomes

Primary Outcomes

Febrile neutropenia

Time Frame: 2 years

Number of participants with febrile neutropenia

Treatment-related hospitalization

Time Frame: 2 years

Number of participants admitted to emergency for treatment-related reasons

Secondary Outcomes

  • Chemotherapy dose reduction(2 years)
  • Chemotherapy discontinuation(2 years)
  • Chemotherapy dose delay(2 years)

Study Sites (1)

Loading locations...

Similar Trials