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

Early-stage Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04781959
• Other study ID #: REaCT-5G
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 9, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 233
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer

Intervention

Drug:
• Filgrastim
Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy
• Pegfilgrastim
Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone pain	Bone pain over the first 5 days after the administration of G-CSF. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) based on a patient's daily pain score, starting after the first dose of G-CSF injection.	5 days after first G-CSF injection
Secondary	Incidence of Febrile Neutropenia	Number of times participants have Febrile neutropenia during chemotherapy treatment	2.5 years after study initiation
Secondary	Incidence of treatment-related hospitalizations	Number of times participants have a treatment-related hospitalization	2.5 years after study initiation
Secondary	Incidence of chemotherapy alteration	Number of times participants have a chemotherapy alteration including: dose delay, reduction and/or discontinuation	2.5 years after study initiation
Secondary	Incidence of chemotherapy-related mortality	Number of times there is a chemotherapy-related mortality	2.5 years after study initiation
Secondary	Rate of G-CSF compliance as prescribed	Number of times there is a G-CSF compliance	2.5 years after study initiation
Secondary	Differences in healthcare resource utilization	Differences in healthcare resource utilization: number of emergency room visits, number of planned/unplanned provider clinic visits (including stretcher bay), patient-reported phone calls or email to patient support line or provider, and additional medication use or management strategies related to G-CSF side effects or efficacy	2.5 years after study initiation
Secondary	HR-QoL	HR-QoL based on EQ-5D-5L	2.5 years after study initiation
Secondary	Cost-effectiveness	Cost differences associated with prescribing Filgrastim and Pegfilgrastim	2.5 years after study initiation
Secondary	Patient G-CSF preference	To survey patient preference in selection of G-CSF treatment before and after undergoing chemotherapy and G-CSF treatment	2.5 years after study initiation
Secondary	Study feasibility	Interim analysis/feasibility. After the first year of study initiation, if study recruitment is less than 30% at one year (70 patients), or if there are unanticipated safety issues, a review of study conduct will be performed to consider stopping the study unless there are unexpected or exceptional reasons, or in the case of low recruitment, there is a plan to boost recruitment efforts	1 year after study initiation