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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2023-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Early-stage Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5 Days of Filgrastim

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

Group Type ACTIVE_COMPARATOR

Filgrastim

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Pegfilgrastim

Intervention Type DRUG

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

Interventions

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Filgrastim

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

Intervention Type DRUG

Pegfilgrastim

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

Intervention Type DRUG

Other Intervention Names

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Neupogen Neulasta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No