Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 12:46 PM
Study NCT ID:
NCT00211133
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex (Epoetin Alfa) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-11
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:
The purpose of this study is to evaluate the impact on survival and quality of life of maintaining hemoglobin in the range of 12 to 14 g/dL using epoetin alfa or placebo in patients starting chemotherapy for metastatic breast cancer for the first time.
Detailed Description:
Cancer patients often experience anemia due to the disease itself, chemotherapy or both. Quality of life is also affected, due in part to the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer.This randomized, double-blind, placebo-controlled multi-center study evaluated the effects of treatment with epoetin alfa in maintaining hemoglobin levels between 12 and 14 g/dL to determine its impact on survival and quality of life, in addition to investigating the possible role that epoetin alfa may have on tumor response to chemotherapy. During the double-blind portion of the study, patients were to receive 12 months of treatment with epoetin alfa or placebo. Thereafter, follow-up evaluations were to occur every 3 months until 75% of the patients had died. Effectiveness was to be determined by recording the number of patients surviving at 12 months, the change in hemoglobin from the start of the study until study completion, response to chemotherapy and quality of life. Safety evaluations (incidence of adverse events, physical examinations and clinical laboratory tests) were to be performed throughout the study. The study hypothesis was that maintaining hemoglobin in the range of 12 to 14 g/dL would improve 12-month survival and quality of life in patients with metastatic breast cancer who were receiving chemotherapy. Since the time this study was originally designed, the prescribing information for epoetin alfa has changed. Current use of epoetin alfa should follow the prescribing information. Patients were to receive epoetin alfa injections (40,000 units) under their skin once per week for 12 months or matching placebo. Dosage was to be adjusted up (to 60,000 units) or down (to 75% of the last dose administered) as needed to maintain hemoglobin levels between 12 and 14 g/dL.
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?: