A Pilot Study of the Effect of Erlotinib (Tarceva®) on Biomarkers in Estrogen Receptor Negative Breast Cancer Expressing the Epidermal Growth Factor Receptor and Interleukin 1a
I. To estimate the effect of erlotinib (Tarceva®) (erlotinib hydrochloride) on expression of
interleukin (IL)-1 alpha (a) in patients with estrogen receptor (ER-) negative, epidermal
growth factor receptor (EGFR-) positive and IL-1a-positive breast cancer.
I. To estimate the effect of erlotinib (Tarceva®) on expression of nuclear factor
kappa-light-chain-enhancer of activated B cells (NF-κB) and amphiregulin (AR) in patients
with ER-negative, EGFR-positive and IL-1a-positive breast cancer.
II. To estimate the effect of erlotinib on tumor cell proliferation (Ki67) and apoptosis
(terminal deoxynucleotidyl transferase deoxyuridine triphosphate [dUTP] nick end labeling
III. To estimate the rates of IL-1a, nuclear NF-κB, and AR expression in patients with
ER-negative, EGFR-positive breast cancer.
IV. To follow the clinical course of patients with resectable ER-negative, EGFR-positive and
IL-1a-positive breast cancer.
V. To assess the toxicity of a 15-day regimen of daily oral administration of erlotinib
(Tarceva®) in participants with ER-negative, EGFR-positive and IL-1a-positive breast cancer.
Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days -14-0
immediately prior to scheduled surgery. Treatment continues in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 week, and then every 6
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effect of erlotinib hydrochloride on expression of IL-1a in patients with ER- negative, EGFR- positive and (IL-)1a-positive breast cancer
IL-1a will be assessed as a binary variable. The association of IL-1a expression with each of the other biomarkers at baseline and with change after therapy will be described graphically and assessed in exploratory analyses using Wilcoxon rank sum tests. Prevalence of IL-1α, in the screened population, will be estimated as a proportion and 95% binomial confidence limits, calculated using Wilson's method to determine precision of the estimates.
Baseline and day 0
Barbara Ann Karmanos Cancer Institute
United States: Food and Drug Administration
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|