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

NCT04781959 | Completed Phase 4

• 1 other identifier: REaCT-5G
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 2

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.

Conditions

Early-stage Breast Cancer

Keywords

Filgrastim; Pegfilgrastim

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Incidence of Febrile Neutropenia

  2.5 years after study initiation

• Incidence of treatment-related hospitalizations

  2.5 years after study initiation

• Incidence of chemotherapy alteration

  2.5 years after study initiation

• Incidence of chemotherapy-related mortality

  2.5 years after study initiation

• Rate of G-CSF compliance as prescribed

  2.5 years after study initiation

Study Arms (2)

5 Days of Filgrastim

ACTIVE COMPARATOR

Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy.

Drug: Filgrastim

Pegfilgrastim

ACTIVE COMPARATOR

Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy

Drug: Pegfilgrastim

Interventions

Filgrastim DRUG

Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy

Also known as: Neupogen

5 Days of Filgrastim

Pegfilgrastim DRUG

Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy

Also known as: Neulasta

Pegfilgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Terry Ng, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: June 9, 2021
• Primary Completion: February 23, 2023
• Study Completion: September 28, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

CA (2)