NCT00030758

Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer

G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 816 (estimated)
• Sponsor: Anglo Celtic Cooperative Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether filgrastim or pegfilgrastim is more effective than standard treatment in preventing neutropenia in women who are receiving adjuvant chemotherapy for breast cancer. PURPOSE: Randomized phase IV trial to compare the effectiveness of filgrastim or pegfilgrastim with that of standard treatment in preventing neutropenia in women who are receiving chemotherapy after undergoing surgery for breast cancer.

Detailed description

OBJECTIVES: * 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 only. * 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.

Conditions

• Breast Cancer
• Neutropenia

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
BIOLOGICAL	pegfilgrastim

Timeline

• Start date: 2001-10-01
• First posted: 2003-01-27
• Last updated: 2013-08-07

Locations

32 sites across 1 country: United Kingdom