Lapatinib and Bevacizumab for Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2020-06-19
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis; Novartis Pharmaceuticals
• Treatments: Bevacizumab; Lapatinib

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