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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876070
• Other study ID #: SCRI OUTCOMES 02
• 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

• Breast Neoplasms
• Metastatic Breast Cancer

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