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Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer

Sponsor
SCRI Development Innovations, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT00876070
Collaborator
Celgene Corporation (Industry)
198
Enrollment
2
Locations
27
Duration (Months)
99
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a retrospective medical record abstraction study. It is a review and evaluation of up to 300 metastatic breast cancer patients treated with Abraxane or other taxanes such as paclitaxel and docetaxel to determine the overall cost of care for Abraxane compared to other taxanes in the first-line metastatic cancer setting and the cost of care for Abraxane compared to other taxanes when broken down by individual components of cost. In addition, the investigators will review the following patient outcomes: response rate, duration of therapy, toxicity, and survival.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    198 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer
    Study Start Date :
    Nov 1, 2008
    Actual Primary Completion Date :
    Nov 1, 2009
    Actual Study Completion Date :
    Feb 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Describe patient demographics, disease and treatment characteristics. [6 months]

    Secondary Outcome Measures

    1. Describe detailed treatment and response characteristics. [6 months]

    2. Describe resource utilization and cost variables. [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients that have received Abraxane chemotherapy greater than three months from the time of chart review.

    • Patients that have received taxane chemotherapy greater than three months from the time of chart review.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Georgia Cancer Specialists Atlanta Georgia United States 30341
    2 Tennessee Oncology, PLLC Nashville Tennessee United States 37023

    Sponsors and Collaborators

    • SCRI Development Innovations, LLC
    • Celgene Corporation

    Investigators

    • Study Chair: Jeffrey F Patton, M.D., SCRI Development Innovations, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SCRI Development Innovations, LLC
    ClinicalTrials.gov Identifier:
    NCT00876070
    Other Study ID Numbers:
    • SCRI OUTCOMES 02
    First Posted:
    Apr 6, 2009
    Last Update Posted:
    Nov 21, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by SCRI Development Innovations, LLC
    Metastatic Breast Cancer
    Breast Cancer
    MBC
    Abraxane
    Paclitaxel
    Taxol
    Docetaxel
    Taxotere
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Nov 21, 2011