Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00030758|
Recruitment Status : Unknown
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Neutropenia||Biological: filgrastim Biological: pegfilgrastim||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||816 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer|
|Study Start Date :||October 2001|
- Proportion of patients achieving ≥ 85% of planned dose intensity
- Proportion of patients with ≥ 1 neutropenic event
- Dose intensity achieved
- Cost of management
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030758
|Study Chair:||Robert C.F. Leonard, MD, BS, MB||Charing Cross Hospital|
|Study Chair:||Kirsten Murray||Scottish Cancer Therapy Network|