Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022386
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-08-10
Brief Title:
Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I Stage II or Stage III Breast Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Label Study of PROCRIT Epoetin Alfa in Women Undergoing Adjuvant Chemotherapy for Stage I II or III Breast Cancer
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
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 Epoetin alfa may stimulate red blood cell production to treat patients who have anemia following chemotherapy
PURPOSE Phase IV trial to study the effectiveness of epoetin alfa in treating chemotherapy-related anemia in women who have stage I stage II or stage III breast cancer
PURPOSE Phase IV trial to study the effectiveness of epoetin alfa in treating chemotherapy-related anemia in women who have stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Determine the effectiveness and safety of epoetin alfa in patients receiving adjuvant chemotherapy for stage I II or III breast cancer II Determine the clinical outcomes in these patients receiving this drug
OUTLINE This is a multicenter study Patients receive epoetin alfa subcutaneously once weekly for up to 24 weeks in the absence of unacceptable toxicity Quality of life is assessed at baseline at week 13 and at study completion
PROJECTED ACCRUAL A maximum of 2500 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive epoetin alfa subcutaneously once weekly for up to 24 weeks in the absence of unacceptable toxicity Quality of life is assessed at baseline at week 13 and at study completion
PROJECTED ACCRUAL A maximum of 2500 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2002 | Registry Identifier | PDQ Physician Data Query | None |
| UCLA-0011004 | None | None | None |
| CDR0000068811 | REGISTRY | None | None |
| ORTHO-PR-01-27-003 | None | None | None |