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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

242 Participants
are divided into 2 treatment groups

Locations

3
Kingston Health Sciences CentreK7L 2V7, KingstonOntario, Canada
Lakeridge HealthL1G 2B9, OshawaOntario, Canada
The Ottawa Hospital Cancer CentreK1H 8L6, OttawaOntario, Canada

Sponsors and collaborators

Ottawa Hospital Research Institute

Lead sponsor