Status:
COMPLETED
A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Early-stage Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
REaCT-5G will compare bone pain from a single dose of Pegfilgrastim to 5 doses of daily filgrastim in breast cancer patients receiving neoadjuvant/adjuvant chemotherapy.
Detailed Description
The use of granulocyte colony-stimulating factors (G-CSF) significantly reduces febrile neutropenia (FN) risk and has helped maintain dose intensity and dose density when treating breast cancer with c...
Eligibility Criteria
Inclusion
- Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
- Able to provide verbal consent
- Able to complete questionnaires in English or French
Exclusion
- No access to pegfilgrastim or filgrastim prior to randomization
- Metastatic cancer
- Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2023
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT04781959
Start Date
June 9 2021
End Date
September 28 2023
Last Update
March 21 2025
Active Locations (2)
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1
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
2
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4