Clinical trial NCT00503841
Conditions: Breast Cancer
Keywords: stage I breast cancer recurrent breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2007-12-01; Completion date: 2010-05-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: 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.
Interventions: intervention 1: erlotinib hydrochloride intervention 2: immunohistochemistry staining method intervention 3: laboratory biomarker analysis intervention 4: biopsy intervention 5: conventional surgery intervention 6: neoadjuvant therapy
Intervention descriptions: intervention 1: 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. intervention 2: Assessed at the time of the initial biopsy and at the time of surgery. intervention 3: Correlative studies intervention 4: 14 days prior to surgery intervention 5: 14 days after taking study drug erlotinib hydrochloride. intervention 6: 14 days after taking study drug erlotinib hydrochloride.

Protocol documents: