Back to resultsTreatment for Patients Suffering From Anemia Due to Chemotherapy
Primary Purpose
Breast Cancer, Anemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Darbepoetin Alfa
Recombinant Human Erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, darbepoetin alfa, Amgen
Eligibility Criteria
Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (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
Sites / Locations
Outcomes
Primary Outcome Measures
Anemia correction
Secondary Outcome Measures
Activities of daily living, patient preference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00120692
Brief Title
Treatment for Patients Suffering From Anemia Due to Chemotherapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in female breast cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Anemia
Keywords
breast cancer, darbepoetin alfa, Amgen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Darbepoetin Alfa
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Erythropoietin
Primary Outcome Measure Information:
Title
Anemia correction
Secondary Outcome Measure Information:
Title
Activities of daily living, patient preference
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Female subjects receiving multi-cycle chemotherapy - Anemia due to chemotherapy (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16381629
Citation
Senecal FM, Yee L, Gabrail N, Charu V, Tomita D, Rossi G, Schwartzberg L. Treatment of chemotherapy-induced anemia in breast cancer: results of a randomized controlled trial of darbepoetin alfa 200 microg every 2 weeks versus epoetin alfa 40,000 U weekly. Clin Breast Cancer. 2005 Dec;6(5):446-54. doi: 10.3816/cbc.2005.n.050.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Treatment for Patients Suffering From Anemia Due to Chemotherapy
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