About this trial
The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Granulocyte Colony-Stimulating Factor (G-CSF)
- Omission of Granulocyte Colony-Stimulating Factor (G-CSF)
Treatment groups
Locations
3Sponsors and collaborators
Ottawa Hospital Research Institute
Lead sponsor