Actively Recruiting
Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy
Led by Ottawa Hospital Research Institute · Updated on 2026-02-09
242
Participants Needed
3
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- No access to pegfilgrastim or filgrastim prior to randomization
- Metastatic cancer
- Known hypersensitivity to filgrastim or pegfilgrastim or any of its components
- Received cytotoxic chemotherapy within the last 5 years
- Uncontrolled inter-current illness or other significant diseases or disorders that would limit compliance or exclude participation according to investigator's opinion
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
2
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Actively Recruiting
3
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
L
Lisa Vandermeer, MSc
CONTACT
C
Carol Stober
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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