Evaluating the need for G-CSF in breast cancer patients on chemotherapy
A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)
This study is testing if breast cancer patients on a specific chemotherapy can skip a medication called G-CSF to see if it helps reduce side effects without affecting their treatment success.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 3 sites (Kingston, Ontario and 2 other locations) |
| Trial ID | NCT05753618 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant chemotherapy requiring G-CSF prophylaxis.
Not a fit: Patients with metastatic cancer or those who have received prior cytotoxic chemotherapy within the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced side effects and improved quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have suggested that omitting G-CSF during the paclitaxel portion of chemotherapy is safe and feasible, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kingston, Ontario and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.