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.
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
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
Parallel
Granulocyte Colony-Stimulating Factor (G-CSF)
DrugParticipants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy.
Omission of Granulocyte Colony-Stimulating Factor (G-CSF)
DrugParticipants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy
Patient-reported bone pain during cycle 1 of paclitaxel
The primary outcome is patient-reported bone pain from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) using the trapezoidal quadrature method for patients reported daily pain score from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. Day 1 being the morning after first dose of G-CSF injection, or 48 hours after chemotherapy injection in the No G-CSF arm. The daily pain score ranges from 0-40. Peak pain is defined as the maximum pain rating over day 1 to day 5. To reiterate the scoring system, every morning, patients are asked to rate the most severe pain they experienced in the last 24 hours on a visual analogue scale (VAS) from 0 (no pain) to 10 (pain as bad as you can imagine). The X axis of the AUC represents time (i.e., days) and the Y axis represents pain severity (0-10).
Patient-reported bone pain across all paclitaxel cycles
Bone pain mean AUC across all cycles of paclitaxel chemotherapy. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) using the trapezoidal quadrature method for patients reported daily pain score from day 1 to 5 during all cycles of paclitaxel chemotherapy. Day 1 being the morning after first dose of G-CSF injection, or 48 hours after chemotherapy injection in the No G-CSF arm. The daily pain score ranges from 0-40. Peak pain is defined as the maximum pain rating over day 1 to day 5. To reiterate the scoring system, every morning, patients are asked to rate the most severe pain they experienced in the last 24 hours on a visual analogue scale (VAS) from 0 (no pain) to 10 (pain as bad as you can imagine). The X axis of the AUC represents time (i.e., days) and the Y axis represents pain severity (0-10).
Peak bone pain experienced
Peak bone pain experienced across all cycles of paclitaxel. Measured by the patient reported daily pain score from days 1 to 5 during all 4 cycles of paclitaxel chemotherapy. Bone pain is measured on a scale ranging from 0-10, 0 being no pain and 10 being the worst possible pain.
Patient health-related quality of life
Patient Health-Related Quality of Life (HR-QoL) based on the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire.
Rates of completion of 4 cycles of paclitaxel
Rates of completion of 4 cycles of paclitaxel chemotherapy within 7 weeks (days 1 cycle 5 to day 1 cycle 8 of chemotherapy)
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