Evaluating the need for G-CSF in breast cancer patients on chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess whether granulocyte colony-stimulating factors (G-CSF) are necessary for breast cancer patients undergoing the paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel chemotherapy. Participants will be randomly assigned to either receive G-CSF or to omit it during treatment. The study seeks to determine if omitting G-CSF can reduce side effects such as bone pain and fever, while still maintaining effective treatment outcomes. The trial builds on previous findings suggesting that it may be safe to forgo G-CSF in this context.

Why it matters

Who can join: the full rules

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

Where it's running

• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Recruiting
• Lakeridge Health
  Oshawa, Ontario, Canada Recruiting
• The Ottawa Hospital Cancer Centre
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Xinni Song, MD — Ottawa Hospital Research Institute
• Study coordinator: Lisa Vandermeer, MSc
• Email: lvandermeer@ohri.ca
• Phone: 613-737-7700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.