Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer
- To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as
measured by a reduction in Ki67 and/or an increase in terminal deoxynucleotidyl
transferase-mediated deoxyuridine triphosphate-biotin nick end labeling
(TUNEL)-positive tumor cells in patients with treatment-naive, operable breast cancer.
- To identify a molecular profile, based on measurements of Estrogen Receptor (ER),
Epidermal Growth Factor Receptor (EGFR), and a Human Epithelial Growth Factor
Receptor-2(HER2), and protein expression profiles in patients with treatment-naïve,
operable breast cancer that is responsive to erlotinib hydrochloride.
- To correlate tumor concentrations of erlotinib hydrochloride with serum levels
immediately before surgery.
OUTLINE: This is a multi-center study.
Patients receive oral erlotinib hydrochloride once daily for 5-14 days. Patients then
undergo surgical resection within 24 hours after the last dose of erlotinib hydrochloride.
Tumor tissue samples are collected at baseline and during surgery for correlative laboratory
studies. Tissue samples are stained for ER, HER2, and EGFR levels, proliferation (Ki67), and
apoptosis (TUNEL) by immunohistochemistry. Levels of erlotinib hydrochloride in tissue
samples are measured by matrix-assisted laser desorption/ionization mass spectrometry. Blood
samples are collected on the day of surgery. Levels of erlotinib hydrochloride in blood
samples are measured by liquid chromatography/mass spectrometry.
Patients are followed within 6 weeks after surgery.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.
Carlos L. Arteaga, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC BRE 0222
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Meharry Medical College||Nashville, Tennessee 37208-3599|
|University of Alabama, Birmingham||Birmingham, Alabama 35233|
|Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599-7305|