An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Anemia
Female
Breast Cancer, Anemia
Trial Information
An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Female Breast Cancer Patients Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
Inclusion Criteria:
- Female subjects receiving multi-cycle chemotherapy - Anemia due tochemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or
equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky
Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate
liver function Exclusion Criteria: - Iron deficiency - Unstable cardiac disease - Known
positive test for human immunodeficiency virus (HIV) infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Anemia correction
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Institutional Review Board
Study ID:
20020152
NCT ID:
NCT00120692
Start Date:
October 2002
Completion Date:
December 2003
Related Keywords:
- Breast Cancer
- Anemia
- breast cancer
- darbepoetin alfa
- Amgen
- Anemia
- Breast Neoplasms
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