A Phase II Open-Label Trial to Evaluate the Efficacy and Toxicity of Tarceva (Erlotinib) in Women With Metastatic, Hormone Receptor Negative and Her2-Negative Breast Cancer
This is a Phase II, open-label, single institution trial of treatment with single agent
erlotinib. The purpose of the research is to determine the effects erlotinib has on the
breast cancer tumors in women with metastatic hormone receptor negative and HER2-negative
breast cancer. The Federal Drug Administration (FDA) has approved erlotinib, also known as
Tarceva, for the treatment of locally advanced and metastatic non-small cell lung cancer.
To qualify for the trial, subjects must have histologically confirmed, incurable, locally
advanced or metastatic breast cancer that is ER-negative, PR-negative, Her2/neu-negative and
EGFR-positive. Subjects must have measurable disease. They must have received less than or
equal to 1 chemotherapeutic agent in the metastatic setting. The target accrual is 43
subjects. Initially, 18 subjects will be accrued. If at least 3 subjects are
progression-free at 4 months, accrual will continue to a maximum of 43 subjects. Subject
eligibility will be evaluated during a screening period of 4 weeks. During the treatment
period, subjects will receive single agent erlotinib, 150mg/day. Subjects will receive the
first dose of erlotinib on Day 0, within 7 days of registration. Efficacy will be assessed
by radiographic tumor assessment or photographic documentation. Safety will be assessed by
the recording of adverse events and laboratory test results. Subjects with documented
progressive disease will be discontinued from treatment and will be followed for survival
information every 2 months until death, lost to follow-up or study termination.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to determine progression free survival. This is defined as the time from the day of initial treatment (Day 0) until documented disease progression or death.
Cannot be determined
No
Ruta D Rao, MD
Principal Investigator
Rush University Medical Center
United States: Institutional Review Board
OSI-TAR-721
NCT00597597
April 2007
April 2011
Name | Location |
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Rush University Medical Center Division of Hematology/Oncology | Chicago, Illinois 60612 |