Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05753618). StuddyBuddy aggregates publicly available trial information.