← Back to all trials
Not Yet Recruiting
NCT05753618
Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy
Conditions: Early-stage Breast Cancer
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 240
Sponsor: Ottawa Hospital Research Institute
Location: Canada
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 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-CSFAble to provide verbal consentAble to complete questionnaires in English or FrenchExclusion Criteria:No access to pegfilgrastim or filgrastim prior to randomizationMetastatic cancerKnown hypersensitivity to filgrastim or pegfilgrastim or one of its componentsPatients received prior cytotoxic chemotherapy within the last 5 yearsPatients 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
Source: ClinicalTrials.gov (NCT05753618). StuddyBuddy aggregates publicly available trial information.