RecruitingPhase 4NCT05753618

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


Sponsor

Ottawa Hospital Research Institute

Enrollment

242 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether certain breast cancer patients can safely skip part of the white blood cell booster shots (G-CSF, such as Neulasta) given during a specific phase of dense-dose chemotherapy (the paclitaxel portion), without increasing the risk of serious infection. **You may be eligible if...** - You have early-stage or locally advanced breast cancer - You are receiving dose-dense AC/T chemotherapy (a common breast cancer regimen) as either pre- or post-surgery treatment - You require G-CSF prophylaxis as part of your chemotherapy plan - You can complete questionnaires in English or French **You may NOT be eligible if...** - You have metastatic breast cancer - You have a known allergy to filgrastim or pegfilgrastim - You do not have access to the required G-CSF medications before starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGranulocyte Colony-Stimulating Factor (G-CSF)

Participants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy.

DRUGOmission of Granulocyte Colony-Stimulating Factor (G-CSF)

Participants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy


Locations(3)

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Lakeridge Health

Oshawa, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05753618


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