A Randomized, Multicentre 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

Titre officiel

A Randomized, Multicentre 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)

Sommaire:

L’étude REaCT-5G compare les douleurs osseuses provoquées par une dose unique de pegfilgrastim à celles qui sont associées à 5 doses de filgrastim quotidiennes chez des patientes atteintes d’un cancer du sein et recevant une chimiothérapie néoadjuvante/adjuvante.

Description de l'essai

Primary Outcome:

• Bone pain

Secondary Outcome:

• Incidence of Febrile Neutropenia
• Incidence of treatment-related hospitalizations
• Incidence of chemotherapy alteration
• Incidence of chemotherapy-related mortality
• Rate of G-CSF compliance as prescribed
• Differences in healthcare resource utilization
• HR-QoL
• Cost-effectiveness
• Patient G-CSF preference
• Study feasibility

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, multicentre, open-label, randomized clinical trial to compare bone pain experienced by patients receiving either PEG or 5-day-FIL with neoadjuvant or adjuvant chemotherapy.

Voir cet essai sur ClinicalTrials.gov