Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00525161|
Recruitment Status : Terminated (Slow accrual and loss of funding)
First Posted : September 5, 2007
Results First Posted : January 13, 2015
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: sorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2015|
Experimental: Sorafenib & Endocrine Therapy
Sorafenib & Endocrine Therapy
400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Other Name: Nexavar
- Response Rate [ Time Frame: 12 weeks after treatment & 8 weeks after initial documentation of response ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.
- Time to Progression [ Time Frame: continuously ]
- Clinical Benefit Rate [ Time Frame: 24 weeks ]Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.
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): NCT00525161
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Suleiman Massarweh, MD||University of Kentucky|