NCT00503841

Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial is studying how well erlotinib works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.

Detailed description

OBJECTIVES: Primary * 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 breast cancer. Secondary * 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 cancer. * To estimate the effect of erlotinib on tumor cell proliferation (Ki67) and apoptosis (TUNEL). * 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 cancer. 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
OTHER	immunohistochemistry staining method	Assessed at the time of the initial biopsy and at the time of surgery.
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	biopsy	14 days prior to surgery
PROCEDURE	conventional surgery	14 days after taking study drug erlotinib hydrochloride.
PROCEDURE	neoadjuvant therapy	14 days after taking study drug erlotinib hydrochloride.

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-02-01
• Completion: 2010-05-01
• First posted: 2007-07-19
• Last updated: 2019-04-30
• Results posted: 2013-02-12

Locations

1 site across 1 country: United States