A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer
- Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of
approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment
patients may receive an injection of darbepoetin alfa in addition to chemotherapy if
their red blood cell count is below normal levels.
- On the day after chemotherapy treatment, patients will receive an injection of
pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total
of 8 injections. Once the patient has finished chemotherapy and the last of the
pegfilgrastim shots, their participation in this trial will be complete.
- While on this study the following procedures will be performed: a physical exam will be
done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2
- This study also involves a Quality of Life Questionnaire done at the beginning of study
treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study
- Patients will remain on this study unless they experience unacceptable side effects
from any of the treatment drugs.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.
Harold Burstein, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Faulkner Hospital||Jamaica Plain, Massachusetts 02130|
|Lowell General Hospital||Lowell, Massachusetts 01854|
|North Shore Cancer Center||Peabody, Massachusetts 01960|