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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00876070
Other study ID # SCRI OUTCOMES 02
Secondary ID
Status Completed
Phase N/A
First received April 2, 2009
Last updated November 18, 2011
Start date November 2008
Est. completion date February 2011

Study information

Verified date November 2011
Source SCRI Development Innovations, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date February 2011
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Georgia Cancer Specialists Atlanta Georgia
United States Tennessee Oncology, PLLC Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
SCRI Development Innovations, LLC Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Describe patient demographics, disease and treatment characteristics. 6 months No
Secondary Describe detailed treatment and response characteristics. 6 months No
Secondary Describe resource utilization and cost variables. 6 months No
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