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Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00217399
First received: September 20, 2005
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
Results First Received: March 23, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: sorafenib tosylate
Drug: anastrozole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 22-Sep-2005 through 01-Jul-2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sorafenib and Anastrozole A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.

Participant Flow:   Overall Study
    Sorafenib and Anastrozole  
STARTED     35  
COMPLETED     35  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Sorafenib and Anastrozole A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.

Baseline Measures
    Sorafenib and Anastrozole  
Number of Participants  
[units: participants]
 		  35  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation 		  55  ± 30  
Gender  
[units: participants]
 		 
Female     35  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     35  



  Outcome Measures
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1.  Primary:   Complete Response + Partial Response + Stable Disease > 24 Weeks   [ Time Frame: 24 weeks ]
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2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 1 year ]
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3.  Secondary:   Tumor Marker Analysis   [ Time Frame: 1 year ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Claudine Isaacs
Organization: Georgetown University
phone: 202-444-3677
e-mail: isaacsc@georgetown.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217399     History of Changes
Other Study ID Numbers: NCI-2009-00069, 2004-251, CDR0000440067
Study First Received: September 20, 2005
Results First Received: March 23, 2011
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration