Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent activity in previously treated advanced breast cancer. This trial will test combined VEGF inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced breast cancer.
OUTLINE: This is a multi-center study. Sorafenib 200mg po daily Bevacizumab 5mg/kg every other week 1 Cycle = 4 weeks Imaging every third cycle Acceptable toxicity and non-PD = Protocol therapy will continue Un-acceptable toxicity or PD = Protocol therapy will be discontinued ECOG Performance Status 0-1 Life Expectancy: at least 12 weeks Hematopoietic: * Platelets \> 100 K/mm3 * Absolute neutrophil count (ANC) \> 1.5 K/mm3 * Hemoglobin \> 10 g/dL Hepatic: * Total Bilirubin \< 1.5 x ULN * Aspartate aminotransferase (AST, SGOT) \< 2 x ULN (up to 5 x ULN in patients with known liver involvement) Renal: * Creatinine \< 1.5 x ULN * No proteinuria as demonstrated by either Urine protein:creatinine (UPC) ratio \< 1.0 or Urine dipstick for proteinuria \< 2+ Cardiovascular: * No known myocardial infarction, unstable angina, \> grade II New York Heart Association (NYHA) classification, congestive heart failure, uncontrolled hypertension defined as SBP \>150 or DBP \>100, \> grade II peripheral vascular disease or significant vascular disease (e.g. aortic aneurysm, aortic dissection) within 12 months prior to being registered for protocol therapy. * No uncontrolled or clinically significant arrhythmia. NOTE: Controlled atrial fibrillation is allowed. * LVEF ≥ LLN by MUGA or ECHO as obtained within 28 days prior to being registered for protocol therapy. Pulmonary: * No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within 28 days prior to being registered for protocol therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Sorafenib 200mg po daily
Bevacizumab 5mg/kg every other week 1 Cycle = 4 weeks
Imaging every third cycle
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States
Progression-Free Survival
The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
Time frame: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.
Time frame: 6 months
Assess the Overall Response Rate.
Time frame: 24 months
Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.
Time frame: 24 months
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