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

RecruitingPhase 4Ages 18 Years - anyAllOttawa Hospital Research Institute
NCT05753618 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Granulocyte Colony-Stimulating Factor (G-CSF)
  • Omission of Granulocyte Colony-Stimulating Factor (G-CSF)
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Where

3 sites
Kingston Health Sciences Centre
Kingston, Canada
Lakeridge Health
Oshawa, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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