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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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

Official Title

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

Keywords

Neoplasms, Breast VEGF Tyrosine kinase ErbB2 Her2-neu metastatic breast cancer EGFR ErbB1 bevacizumab lapatinib

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis
ID
NCT00444535
Phase
Phase 2
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
January 1, 2017