Comparing Use Versus Omission of Granulocyte Colony-Stimulating Factors During Paclitaxel Treatment in Early-Stage Breast Cancer Patients Receiving Dose-Dense Adriamycin-Cyclophosphamide and Paclitaxel Chemotherapy

What this Trial Is About

Researchers are evaluating the omission of granulocyte colony-stimulating factors G-CSF during the paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel DD-ACT chemotherapy in patients with early-stage or locally-advanced breast cancer. The goal is to determine if skipping G-CSF is safe, feasible, and improves patient-reported bone pain and health-related quality of life. This is a randomized, pragmatic clinical trial motivated by concerns that G-CSF can cause bone pain and fever, potentially leading to additional clinical visits. Participants are randomly assigned to one of two groups one group receives G-CSF injections either filgrastim or pegfilgrastim after each paclitaxel chemotherapy cycle, and the other group omits G-CSF injections during those cycles. The treatment cycles are administered every 14 days as part of the dose-dense chemotherapy regimen. The study will compare bone pain, quality of life, treatment completion rates, and safety outcomes between the two groups. During the study, participants will report bone pain after each chemotherapy cycle and complete questionnaires assessing quality of life. Researchers will monitor treatment completion, chemotherapy dose intensity, incidence of neutropenia and infections, healthcare resource use, and related hospital visits over an average of 12 weeks. The primary outcome focuses on patient-reported bone pain at the end of the first paclitaxel cycle, with secondary outcomes covering all cycles and other health metrics.

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