A Phase II, Single-Arm, Multi-Center Study Evaluating the Combination of Vinorelbine and Lapatinib in Women with ErbB2 Overexpressing Metastatic Breast Cancer

Study Status

Closed to Enrollment

Study Description

The purpose of this study is to determine the activity of viorelbine plus lapatinib in either first or second line setting in women with ErbB2 overexpressing metastastic breast cancer.

Patients will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib daily. Patients will receive treatment until disease progression or withdrawal from the study.

The primary goal of this study is to evaluate overall tumor response rate of lapatinib in combination with vinorelbine. Secondary goals include progression-free survival, overall survival, duration of response, time to response and time to progression, and safety.  

Disease Status and/or Stage

Metastatic Breast Cancer

Sponsor

GlaxoSmithKline

Key Eligibility

  • Women, age 18 and over
  • Confirmed invasive breast cancer with Stage IV disease at primary diagnosis or at relapse after curative-intent surgery
  • Determined by investigator to have life expectancy of ≥ 12 weeks
  • Documented amplification of ErbB2 3+
  • Must not have received more than 1 prior chemotherapeutic regimen in the metastic setting
  • All prior chemotherapy, immunotherapy, biologic therapy, or surgery (except for minor surgical procedures) must be discontinued at least 4 weeks prior to first dose of study drug
  • Hormonal therapy must be discontinued at least 1 week prior to first dose of study drug
  • Other entry criteria will be discussed with you when you contact the study team

Principal Investigator

Tessa Cigler, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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