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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Early-stage Breast Cancer
• Intervention / Treatment: Drug: Filgrastim; Drug: Pegfilgrastim

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.

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lisa Vandermeer; Phone Number: 73039 6137377700; Email: lvandermeer@toh.ca
• Study Contact Backup: Name: Carol Stober; Phone Number: 77226 6137377700; Email: cstober@ohri.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Ottawa Hospital Research Institute
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5 Days of Filgrastim; Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy.	Drug: Filgrastim; Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy; Other Names: Neupogen
Active Comparator: Pegfilgrastim; Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy	Drug: Pegfilgrastim; Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy; Other Names: Neulasta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Febrile Neutropenia	Number of times participants have Febrile neutropenia during chemotherapy treatment	2.5 years after study initiation
Incidence of treatment-related hospitalizations	Number of times participants have a treatment-related hospitalization	2.5 years after study initiation
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
Incidence of chemotherapy-related mortality	Number of times there is a chemotherapy-related mortality	2.5 years after study initiation
Rate of G-CSF compliance as prescribed	Number of times there is a G-CSF compliance	2.5 years after study initiation
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
HR-QoL	HR-QoL based on EQ-5D-5L	2.5 years after study initiation
Cost-effectiveness	Cost differences associated with prescribing Filgrastim and Pegfilgrastim	2.5 years after study initiation
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
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Terry Ng, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Filgrastim; Pegfilgrastim
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: REaCT-5G

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No