NCT00120692

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_2 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

June 30, 2005

Last Update Submit

December 20, 2007

Conditions

Breast CancerAnemia

Keywords

breast cancerdarbepoetin alfaAmgen

Outcome Measures

Primary Outcomes (1)

  • Anemia correction

Secondary Outcomes (1)

  • Activities of daily living, patient preference

Interventions

Darbepoetin AlfaDRUG
Recombinant Human ErythropoietinDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16381629RESULT

Related Links

MeSH Terms

Conditions

Breast NeoplasmsAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 19, 2005

Study Start

October 1, 2002

Study Completion

December 1, 2003

Last Updated

December 24, 2007

Record last verified: 2007-12