drugset / Trial / NCT05753618

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

NCT05753618

Phase 4 Recruiting 242 enrolled Ottawa Hospital Research Institute
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-04-17
Primary completion
2026-10
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pegfilgrastim Protein / enzyme biologic
Comparator filgrastim Protein / enzyme biologic

Indications