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

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 4

Conditions: Early-stage Breast Cancer

Treatments: Drug: Filgrastim; Drug: Pegfilgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT04781959

REaCT-5G

Details and patient eligibility

About

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.

Full 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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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233 participants in 2 patient groups

5 Days of Filgrastim

Active Comparator group

Description:

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

Treatment:

Drug: Filgrastim

Pegfilgrastim

Active Comparator group

Description:

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

Treatment:

Drug: Pegfilgrastim