All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
Active, not recruiting
Oct 05, 2020
Feb 27, 2007
Dec 31, 2020
18 Years and older (Adult, Older Adult)
1500 mg oral lapatinib (once daily)
10 mg/kg intravenous bevacizumab (every two weeks)
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
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.
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