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

• ClinicalTrials.gov Identifier: NCT02816164
• Recruitment Status: Completed
• First Posted: June 28, 2016
• Last Update Posted: September 6, 2019
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Early Stage Breast Cancer	Drug: Neupogen	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: September 2016
• Actual Primary Completion Date: February 2019
• Actual Study Completion Date: February 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Neupogen for 5 days; Neupogen injection for 5 days	Drug: Neupogen; Subcutaneous injections; Other Name: Filgrastim
Active Comparator: Neupogen for 7 days; Neupogen injection for 7 days	Drug: Neupogen; Subcutaneous injections; Other Name: Filgrastim
Active Comparator: Neupogen for 10 days; Neupogen injection for 10 days	Drug: Neupogen; Subcutaneous injections; Other Name: Filgrastim

Outcome Measures

Primary Outcome Measures :

1. Febrile neutropenia [ Time Frame: 2 years ]
   Number of participants with febrile neutropenia
2. Treatment-related hospitalization [ Time Frame: 2 years ]
   Number of participants admitted to emergency for treatment-related reasons

Secondary Outcome Measures :

1. Chemotherapy dose delay [ Time Frame: 2 years ]
   Number of participants who experience a dose delay with their chemotherapy treatment
2. Chemotherapy dose reduction [ Time Frame: 2 years ]
   Number of participants who experience a dose reduction in their chemotherapy treatment
3. Chemotherapy discontinuation [ Time Frame: 2 years ]
   Number of participants who stop chemotherapy for any reason

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

• Principal Investigator: Mark Clemons, MD; The Ottawa Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT02816164
• Other Study ID Numbers: OTT 16-04
• First Posted: June 28, 2016
• Last Update Posted: September 6, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to make IPD available.

Additional relevant MeSH terms:

Breast Neoplasms; Neutropenia; Febrile Neutropenia; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Hematologic Diseases; Lenograstim; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs