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

Metastatic Breast Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT00632541
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: Phase 2
• Start date: October 2007
• Completion date: March 2009