Lapatinib and Bevacizumab for Metastatic Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Intervention: lapatinib; bevacizumab
Intervention description: 1500 mg oral lapatinib (once daily); 10 mg/kg intravenous bevacizumab (every two weeks)
Intervention MeSH terms: Bevacizumab; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VEGF; Tyrosine kinase; ErbB2; Her2-neu; metastatic breast cancer; EGFR; ErbB1; bevacizumab; lapatinib; breast carcinoma; breast cancer; breast lump; breast cancer positive for human epidermal growth factor receptor 2 (HER2); HER2 positive metastatic breast cancer; breast cancer progression; estrogen-receptor (ER) positive(+) breast cancer; Paget's disease

Summary:

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

Eligibility criteria:

        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