Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Hope Rugo

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, BreastVEGFTyrosine kinaseErbB2Her2-neumetastatic breast cancerEGFRErbB1bevacizumablapatinibBreast Neoplasms

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 FranciscoCalifornia94115United States
  • Novartis Investigative Site
    TucsonArizona85724United States

Lead Scientist

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT00444535
Phase
Phase 2
Study Type
Interventional
Last Updated