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

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00876070
First received: April 2, 2009
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

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
Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Describe patient demographics, disease and treatment characteristics. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe detailed treatment and response characteristics. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Describe resource utilization and cost variables. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: November 2008
Study Completion Date: February 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with Metastatic Breast Cancer from January 2005 to three months prior to site-specific protocol initiation will be eligible. This will include current/actively being treated patients as well as patients who have previously completed therapy.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876070

Locations
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
United States, Tennessee
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
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00876070     History of Changes
Other Study ID Numbers: SCRI OUTCOMES 02
Study First Received: April 2, 2009
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
Metastatic Breast Cancer
Breast Cancer
MBC
Abraxane
Paclitaxel
Taxol
Docetaxel
Taxotere

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014