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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

Early-stage Breast Cancer

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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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

The Ottawa Hospital Cancer Centre
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Lisa Vandermeer, MSc

[email protected]
613-737-7700
Study Sponsored By
Ottawa Hospital Research Institute
Participants Required
More Information
Study ID: NCT05753618