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

Early Stage Breast Cancer Clinical Trial

— REaCT-G2  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816164
• Other study ID #: OTT 16-04
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: February 2019

Study information

• Verified date: September 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Stage Breast Cancer
• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• Neupogen
Subcutaneous injections

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Febrile neutropenia	Number of participants with febrile neutropenia	2 years
Primary	Treatment-related hospitalization	Number of participants admitted to emergency for treatment-related reasons	2 years
Secondary	Chemotherapy dose delay	Number of participants who experience a dose delay with their chemotherapy treatment	2 years
Secondary	Chemotherapy dose reduction	Number of participants who experience a dose reduction in their chemotherapy treatment	2 years
Secondary	Chemotherapy discontinuation	Number of participants who stop chemotherapy for any reason	2 years