G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
- Determine the efficacy of filgrastim (G-CSF) or pegfilgrastim as secondary prophylaxis
versus standard management after the first neutropenic event in maintaining
dose-intensity of adjuvant chemotherapy in patients with early breast cancer.
- Determine the proportion of patients who experience at least one neutropenic event.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(60 and under vs over 60) and participating center.
Patients receive chemotherapy as per local practice. After the first neutropenic event,
patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) for 7 days beginning 2
days after the final dose in a course of adjuvant chemotherapy (e.g., beginning on day
3 for a course of chemotherapy administered on day 1 only OR beginning on day 10 for a
course of chemotherapy administered on days 1 and 8) OR a single dose of pegfilgrastim
SC administered approximately 24 hours after chemotherapy that is administered on day 1
- Arm II: Patients receive standard conservative management. Patients are followed for up
to 10 years.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 7 years.
Allocation: Randomized, Primary Purpose: Supportive Care
Proportion of patients achieving ≥ 85% of planned dose intensity
Robert C.F. Leonard, MD, BS, MB
Charing Cross Hospital
United States: Federal Government