Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2007-02-27
2020-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
TREATMENT
NONE
Study Groups
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Oral lapatinib tablets in combination with IV bevacizumab
1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)
lapatinib
1500 mg oral lapatinib (once daily)
bevacizumab
10 mg/kg intravenous bevacizumab (every two weeks)
Interventions
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lapatinib
1500 mg oral lapatinib (once daily)
bevacizumab
10 mg/kg intravenous bevacizumab (every two weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Hollywood, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Basking Ridge, New York, United States
Novartis Investigative Site
Commack, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Rockville Centre, New York, United States
Novartis Investigative Site
Sleepy Hollow, New York, United States
Countries
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References
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Rugo HS, Chien AJ, Franco SX, Stopeck AT, Glencer A, Lahiri S, Arbushites MC, Scott J, Park JW, Hudis C, Nulsen B, Dickler MN. A phase II study of lapatinib and bevacizumab as treatment for HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):13-20. doi: 10.1007/s10549-011-1918-z. Epub 2011 Dec 24.
Other Identifiers
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CLAP016A2201
Identifier Type: OTHER
Identifier Source: secondary_id
EGF103890
Identifier Type: -
Identifier Source: org_study_id