A study 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.

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.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Patient must have an ECOG performance status ?2
  • Must have adequate hematological
  • Renal and hepatic function
  • Females of childbearing potential must have a negative urine pregnancy test
  • Patient can not have concurrent adjuvant cancer therapy
  • Can not have had prior bone marrow or hematopoietic stem cell transplant
  • Can not have used any investigational drugs
  • Biologics
  • Or devices within 30 days prior to study treatment

What is involved

  • Informed consent
  • Physical exam/history
  • Vital signs
  • Blood samples
  • ECOG
  • Twice daily body temperatures
  • Daily Temp. Log
  • Drug administration

Compensation

Patients will receive compensation for their time and travel related to their participation in this study.

Contact Information

Study Coordinator
Stacey Lewis
Email
stalewis@wakehealth.edu
Phone
336-713-6927
Principal Investigator
Dr. Susan Melin

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.