Clinical trial NCT04781959: 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
Official title: 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 (REaCT-5G)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early-stage Breast Cancer
Keywords: Filgrastim
Pegfilgrastim
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 chemotherapy. This is crucial as survival outcomes are significantly impaired if dose intensity are reduced. National and international guidelines recommend the use of G-CSF as primary prophylaxis with most commonly used breast cancer chemotherapy regimens. Filgrastim (FIL) as a G-CSF that has been in use since the early 90s. Pegfilgrastim (PEG) is a long-acting, pegylated version of FIL that requires only one injection per chemotherapy cycle instead of daily FIL injections for 5 to 10 days per cycle. PEG and FIL both come at the potential cost of bone pain, the most common side effect. G-CSF related bone pain is often severe, leading to refusal or cancellation of G-CSF and early discontinuation of chemotherapy. We propose to perform a pragmatic, multicenter, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* No access to pegfilgrastim or filgrastim prior to randomization
* Metastatic cancer
* Known hypersensitivity to filgrastim or pegfilgrastim or one of its components

Primary outcomes:
measure: Bone pain
timeFrame: 5 days after first G-CSF injection
Secondary outcomes:
measure: Incidence of Febrile Neutropenia
timeFrame: 2.5 years after study initiation
measure: Incidence of treatment-related hospitalizations
timeFrame: 2.5 years after study initiation
measure: Incidence of chemotherapy alteration
timeFrame: 2.5 years after study initiation
measure: Incidence of chemotherapy-related mortality
timeFrame: 2.5 years after study initiation
measure: Rate of G-CSF compliance as prescribed
timeFrame: 2.5 years after study initiation
measure: Differences in healthcare resource utilization
timeFrame: 2.5 years after study initiation
measure: HR-QoL
timeFrame: 2.5 years after study initiation
measure: Cost-effectiveness
timeFrame: 2.5 years after study initiation
measure: Patient G-CSF preference
timeFrame: 2.5 years after study initiation
measure: Study feasibility
timeFrame: 1 year after study initiation
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Terry Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: