Breast Cancer Clinical Trial
Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
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.
Full 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Inclusion
Cytologically or histologically confirmed adenocarcinoma of the breast
Stage I-III disease
BI-RADS 4 or 5 abnormalities on breast imaging and undergoing core needle biopsy for diagnosis
Participants must have a lesion of at least 1-cm on breast imaging studies (mammogram, ultrasound, or MRI)
Participants must have breast cancer amenable to surgery with curative intent and must have agreed to undergo such surgery
The surgical procedure must be scheduled in the near future to accommodate a treatment period of no less and no more than 15 days
Clinically positive for the overexpression of EGFR and interleukin-1α
Clinically negative for expression of the estrogen receptor (ER-negative) and progesterone receptor (PgR-negative)
May be positive or negative for HER2
Exclusion
Locally advanced or metastatic disease not amenable to surgery
Known brain metastases
PATIENT CHARACTERISTICS:
Inclusion
Female
Menopausal status not specified
ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
ANC ≥ 1000/mm³
Platelet count ≥ 75,000/mm³
AST and ALT ≤ 2.5 times upper limits of normal (ULN)
Alkaline phosphatase ≤ 2.5 times ULN
Bilirubin ≤ 2 times ULN
Hemoglobin > 9 g/dL
Creatinine within normal institutional limits OR creatinine clearance >60 mL/min
Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and women within 6 months of menopause
Women of child-bearing potential and their partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion
Pregnant or nursing
History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride
Uncontrolled intercurrent illness including, but not limited to, any of the following:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
Exclusion
Received any other therapy (i.e., surgery, radiation, hormone treatment, biologic therapy, and/or chemotherapy) for the treatment of breast cancer
Concurrent use of anti-neoplastic or anti-tumor agents not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy
Receiving any other investigational agents
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There is 1 Location for this study
Detroit Michigan, 48201, United States
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