RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)
The purpose of this study is to compare the efficacy of a single dose of SPI-2012 with pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the Duration of Severe Neutropenia (DSN) in Cycle 1.
Primary Outcome Measures:
This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 (a long acting myeloid growth factor) with pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in breast cancer patients treated with TC chemotherapy.
Approximately 400 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment arms.
Each cycle will be 21 days. Only 4 cycles will be evaluated for this study. On Day 1 of each cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will receive study drug (SPI-2012 or pegfilgrastim).
View this trial on ClinicalTrials.gov
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