Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)
Status: Not Recruiting
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called SPI-2012 (also known as Rolontis™, eflapegrastim). This is a clinical trial for people who are about to start their first treatment for breast cancer. All participants in this study will receive chemotherapy treatment with docetaxel and cyclophosphamide (also called TC chemotherapy). Treatment with TC chemotherapy may weaken your body’s ability to fight infections by reducing the number of white blood cells in your body. Because of this, all patients in RECOVER will also receive a medication (either pegfilgrastim or SPI-2012) that will increase the number of white blood cells in the body. This study will compare SPI-2012 (eflapegrastim) and pegfilgrastim (NDC code 55513-190-01) along with TC chemotherapy for early stage breast cancer, by collecting blood samples and looking at the number of white blood cells and neutrophils being produced by the body.