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

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ClinicalTrials.gov Identifier: NCT00876070
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : November 21, 2011
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

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
Metastatic Breast Cancer

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 : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Describe patient demographics, disease and treatment characteristics. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Describe detailed treatment and response characteristics. [ Time Frame: 6 months ]
  2. Describe resource utilization and cost variables. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00876070     History of Changes
Other Study ID Numbers: SCRI OUTCOMES 02
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: November 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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Taxane
Antineoplastic Agents