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A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia (REaCT-G2)

Primary Purpose

Early Stage Breast Cancer

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Neupogen
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Breast Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Neupogen for 5 days

Neupogen for 7 days

Neupogen for 10 days

Arm Description

Neupogen injection for 5 days

Neupogen injection for 7 days

Neupogen injection for 10 days

Outcomes

Primary Outcome Measures

Febrile neutropenia
Number of participants with febrile neutropenia
Treatment-related hospitalization
Number of participants admitted to emergency for treatment-related reasons

Secondary Outcome Measures

Chemotherapy dose delay
Number of participants who experience a dose delay with their chemotherapy treatment
Chemotherapy dose reduction
Number of participants who experience a dose reduction in their chemotherapy treatment
Chemotherapy discontinuation
Number of participants who stop chemotherapy for any reason

Full Information

First Posted
June 24, 2016
Last Updated
September 3, 2019
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02816164
Brief Title
A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neupogen for 5 days
Arm Type
Active Comparator
Arm Description
Neupogen injection for 5 days
Arm Title
Neupogen for 7 days
Arm Type
Active Comparator
Arm Description
Neupogen injection for 7 days
Arm Title
Neupogen for 10 days
Arm Type
Active Comparator
Arm Description
Neupogen injection for 10 days
Intervention Type
Drug
Intervention Name(s)
Neupogen
Other Intervention Name(s)
Filgrastim
Intervention Description
Subcutaneous injections
Primary Outcome Measure Information:
Title
Febrile neutropenia
Description
Number of participants with febrile neutropenia
Time Frame
2 years
Title
Treatment-related hospitalization
Description
Number of participants admitted to emergency for treatment-related reasons
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Chemotherapy dose delay
Description
Number of participants who experience a dose delay with their chemotherapy treatment
Time Frame
2 years
Title
Chemotherapy dose reduction
Description
Number of participants who experience a dose reduction in their chemotherapy treatment
Time Frame
2 years
Title
Chemotherapy discontinuation
Description
Number of participants who stop chemotherapy for any reason
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Clemons, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available.
Citations:
PubMed Identifier
32325257
Citation
Clemons M, Fergusson D, Simos D, Mates M, Robinson A, Califaretti N, Zibdawi L, Bahl M, Raphael J, Ibrahim MFK, Fernandes R, Pitre L, Aseyev O, Stober C, Vandermeer L, Saunders D, Hutton B, Mallick R, Pond GR, Awan A, Hilton J. A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer. Ann Oncol. 2020 Jul;31(7):951-957. doi: 10.1016/j.annonc.2020.04.005. Epub 2020 Apr 20.
Results Reference
derived

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

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