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RecruitingPhase 4NCT05753618

Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy

A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)

Sponsor

Ottawa Hospital Research Institute

Enrollment

242 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Summary

The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC/T chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
  • Able to provide verbal consent
  • Able to complete questionnaires in English or French

Exclusion Criteria5

  • No access to pegfilgrastim or filgrastim prior to randomization
  • Metastatic cancer
  • Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
  • Patients received prior cytotoxic chemotherapy within the last 5 years
  • Patients with uncontrolled inter-current illness that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study

Interventions

DRUGGranulocyte Colony-Stimulating Factor (G-CSF)

Participants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy.

DRUGOmission of Granulocyte Colony-Stimulating Factor (G-CSF)

Participants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy

Locations(3)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Lakeridge Health

Oshawa, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

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NCT05753618