Actively Recruiting
A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)
Led by Ottawa Hospital Research Institute · Updated on 2026-02-09
242
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether it is safe and feasible to omit granulocyte colony-stimulating factors (G-CSF) during the paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy in patients with early-stage or locally advanced breast cancer. This randomized clinical trial aims to compare outcomes between patients who receive G-CSF and those who do not during the paclitaxel cycles, focusing on patient-reported bone pain and health-related quality of life. The study builds on prior research suggesting that G-CSF omission might reduce side effects like bone pain without increasing infection risk. Participants will be randomly assigned to one of two groups: one group will receive G-CSF injections (either filgrastim or pegfilgrastim) after each paclitaxel cycle, while the other group will omit G-CSF during these cycles. The chemotherapy cycles occur every 14 days, and the study evaluates the effects of G-CSF use or omission specifically during this paclitaxel phase of DD-AC/T chemotherapy. Both groups receive the same chemotherapy treatment except for the difference in G-CSF administration. Throughout the study, participants will report bone pain after each paclitaxel cycle, with special attention to pain during the first cycle. Researchers will also assess quality of life, chemotherapy completion rates, dose intensity, incidence of febrile neutropenia and hospital visits, healthcare resource use, and related costs over an average of 12 weeks. Safety and treatment-related complications will be monitored to evaluate the feasibility of omitting G-CSF in this setting.
CONDITIONS
Brief Title
Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC/T chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
- Able to provide verbal consent
- Able to complete questionnaires in English or French
You will not qualify if you...
- No access to pegfilgrastim or filgrastim prior to randomization
- Metastatic cancer
- Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
- Patients received prior cytotoxic chemotherapy within the last 5 years
- Patients with uncontrolled inter-current illness that would limit compliance with study requirements or other significant diseases or disorders that would exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive dose-dense Adriamycin-cyclophosphamide chemotherapy followed by paclitaxel chemotherapy. During the paclitaxel portion, participants are randomized to either receive or omit granulocyte colony-stimulating factor (G-CSF) injections after each cycle.
8 bi-weekly visits corresponding to chemotherapy cycles
Trial Site Locations
Total: 3 locations
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
2
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
3
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
L
Lisa Vandermeer, MSc
C
Carol Stober
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here