NCT00632541

A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer

A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Sorafenib	Sorafenib 200mg po daily
DRUG	Bevacizumab	Bevacizumab 5mg/kg every other week 1 Cycle = 4 weeks
OTHER	Imaging	Imaging every third cycle

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-03-10
• Last updated: 2018-02-14
• Results posted: 2016-01-07

Locations

10 sites across 1 country: United States