Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: Cannot be determined ]
- Overall response rate, consisting of complete and partial responses according to RECIST criteria [ Time Frame: Every 8 weeks ]
- Clinical benefit, consisting of complete and partial responses, and stable disease for six months [ Time Frame: Six months ]
- Duration of objective response [ Time Frame: Every 8 weeks ]
- Safety of erlotinib. [ Time Frame: Every 4 weeks ]
- Rash, incidence and severity [ Time Frame: Every 4 weeks ]
|Study Start Date:||April 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Open label; all subjects receive active drug, Erlotinib
During the treatment period, subjects will receive single agent erlotinib, 150mg/day.
Other Name: Tarceva
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597597
|United States, Illinois|
|Rush University Medical Center Division of Hematology/Oncology|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Ruta D Rao, MD||Rush University Medical Center|