What we are studying
This study is to compare the experimental drug SPI-2012 and pegfilgrastim, to help increases the number of white blood cells in your body while you receive chemotherapy with docetaxel and cyclophosphamide for of early stage breast cancer.
Approximately 580 patients with early stage breast cancer will participate in this study at various research centers across North America. You will be assigned to one of 2 study groups, SPI-2012 or pegfilgrastim. The study group assignment is random (like flipping a coin) and cannot be changed. You will not be informed which group you have been assigned to and which study drug you will receive, until you have completed your study participation. The study doctor will know which drug you are receiving, so he or she can make changes in your care, as needed, during the study.
Only 4 treatment cycles will be evaluated for this study, each cycle will be 21 days. You will need to record your body temperature twice every day, using a diary provided to you on Day 1 of each Cycle. If your temperature is greater or equal to 38.0°C (or 100.4°F), contact your doctor immediately. During your clinic visit blood samples (approximately 1 teaspoon) will be taken to determine your complete blood count and blood chemistry. Your vital signs (blood pressure, heart rate, and temperature) will be taken after you receive your treatment. You will also be asked questions about any symptoms or side effects you are having.
You will receive a telephone call, 3 months and 9 months after your last dose of SPI-2012 or pegfilgrastim. You will return to the doctor’s office or clinic, 6 months and 12 months after your last dose of SPI-2012 or pegfilgrastim.
Patients will receive compensation for their time and travel related to their participation in this study.