Lapatinib and Bevacizumab for Metastatic Breast Cancer

A Phase II, Open-Label Study of the Clinical Activity, Safety, and Tolerability of Lapatinib in Combination With Bevacizumab in Subjects With Advanced or Metastatic ErbB2-Overexpressing Breast Cancer

ClinicalTrials.gov Identifier: NCT00444535

Novartis Reference Number: EGF103890

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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. 

Study Description

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

Condition 
Neoplasms, Breast
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
52 participants
Start date 
Feb 27, 2007
Completion date 
Dec 31, 2020
Gender 
Female
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
lapatinib
1500 mg oral lapatinib (once daily)
Drug
bevacizumab
10 mg/kg intravenous bevacizumab (every two weeks)

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

Study Locations

United States
Novartis Investigative Site
-
Tucson, 85724
Arizona
United States
Novartis Investigative Site
-
San Francisco, 94115
California
United States
Novartis Investigative Site
-
Hollywood, 33021
Florida
United States
Novartis Investigative Site
-
Tampa, 33612
Florida
United States
Novartis Investigative Site
-
Basking Ridge, 07920
New York
United States
Novartis Investigative Site
-
Commack, 11725
New York
United States
Novartis Investigative Site
-
New York, 10065
New York
United States
Novartis Investigative Site
-
Rockville Centre, 11570
New York
United States
Novartis Investigative Site
-
Sleepy Hollow, 10591
New York
United States

Have a question?

Call 1-999-669-6682 or email [email protected]