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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00211133 |
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.
Condition | Intervention | Phase |
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Breast Neoplasms Anemia Quality of Life |
Drug: epoetin alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 870 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | December 2006 |
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 pateints 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004414 |
Study First Received: | September 13, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00211133 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Epoetin Female Survival Hemoglobin Breast Tumor |
erythropoietin Chemotherapy Women Epoetin alfa Quality of Life Anemia |
Epoetin Alfa Skin Diseases Hematologic Diseases Anemia |
Quality of Life Breast Neoplasms Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site Hematinics |
Therapeutic Uses Hematologic Agents Pharmacologic Actions |