Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030758
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2002-02-14
Brief Title:
Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
Sponsor:
Anglo Celtic Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
G-CSF Filgrastim or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 persons 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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20143 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069195 | REGISTRY | None | None |
| SCTN-BR0101 | None | None | None |