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 1α
- To estimate the effect of erlotinib hydrochloride on expression of interleukin (IL)-1α
in patients with estrogen receptor (ER-)-negative, EGFR-positive and IL-1α-positive
- To estimate the effect of erlotinib hydrochloride on expression of nuclear NF-κB and
amphiregulin (AR) in patients with ER-negative, EGFR-positive and IL-1α-positive breast
- To estimate the effect of erlotinib on tumor cell proliferation (Ki67) and apoptosis
- To estimate the rates of IL-1α, nuclear NF-κB, and AR expression in patients with
ER-negative, EGFR-positive breast cancer.
- To follow the clinical course of patients with resectable ER-negative, EGFR-positive
and IL-1α-positive breast cancer.
- To assess the toxicity of a 15-day regimen of daily oral administration of erlotinib
hydrochloride in participants with ER-negative, EGFR-positive and IL-1α-positive breast
OUTLINE: This is an open-label, pilot study. Patients are stratified according to HER2
status (positive vs negative).
Patients receive oral erlotinib hydrochloride once daily on days -14 to 0 in the absence of
disease progression or unacceptable toxicity.
Patients undergo surgery on day 0.
Tissue samples are collected at baseline and examined for expression of estrogen receptor,
progesterone receptor, HER2, EGFR, interleukin (IL)-1α, amphiregulin, and NF-kB. Tissue
samples collected at surgery are examined for IL-1α, NF-kB, and amphiregulin by IHC.
Following surgery, patients will be contacted 1 week post-surgery (± 1 day) or 1 week
post-withdrawal from study (± 1 day) by phone call or clinic visit to assess toxicity. After
that, patients will be followed and treated according to standard of care practices. If
patients choose to follow-up with an oncologist outside of our institution, they or their
oncologist will be contacted every 6 months for updated information on their conditions.
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
Baseline and day 0
Elaina M. Gartner, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|