Lapatinib and Bevacizumab for Metastatic Breast Cancer

A Phase II, Open-Label Study of the Clinical Activity, Safety, and Tolerability of Lapatinib in Combination With Bevacizumab in Subjects With Advanced or Metastatic ErbB2-Overexpressing Breast Cancer

This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.

Inclusion criteria:

• Females that are at least 18 years of age.
• Women of childbearing potential must have a negative serum pregnancy test at screening.
• Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.
• Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.
• Adequate hepatic, renal and cardiac function
• ECOG score 0-1 and a life expectancy of at least 12 weeks.
• Able to swallow oral medication
• Signed informed consent

Exclusion criteria:

• Pregnancy
• Unstable or symptomatic CNS metastases
• Major surgery within 28 days of enrollment (minor surgery within 7 days).
• Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.
• A serious non-healing wound, ulcer, or bone fracture at baseline.
• Class II, III or IV heart failure as defined by the NYHA functional classification system
• History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.
• History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.
• History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
• History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.
• Proteinuria
• Requires concurrent anti-cancer treatment or investigational treatment.
• Known hypersensitivity to either study medication
• Received investigational treatment within 28 days or 5 half-lives, whichever is longer
• Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study
• Requires medication that has been excluded during study participation