Status:
COMPLETED
Lapatinib and Bevacizumab for Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neoplasms, Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 27 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00444535
Start Date
February 27 2007
End Date
June 19 2020
Last Update
October 25 2021
Active Locations (9)
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1
Novartis Investigative Site
Tucson, Arizona, United States, 85724
2
Novartis Investigative Site
San Francisco, California, United States, 94115
3
Novartis Investigative Site
Hollywood, Florida, United States, 33021
4
Novartis Investigative Site
Tampa, Florida, United States, 33612