Lapatinib and Bevacizumab for Metastatic Breast Cancer (NCT00444535) | Clinical Trial Compass
CompletedPhase 2
Lapatinib and Bevacizumab for Metastatic Breast Cancer
United States52 participantsStarted 2007-02-27
Plain-language summary
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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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…
What they're measuring
1
Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment