Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer|
- Response Rate [ Time Frame: 12 weeks after treatment & 8 weeks after initial documentation of response ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Clinical Benefit Rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2007|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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
A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525161
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Suleiman Massarweh, MD||University of Kentucky|