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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

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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
breast cancer.


- 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.

Inclusion Criteria



- 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


- Locally advanced or metastatic disease not amenable to surgery

- Known brain metastases



- 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


- 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

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study



- 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

- Receiving any other investigational agents

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer

Outcome Time Frame:

Baseline and day 0

Safety Issue:


Principal Investigator

Elaina M. Gartner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

December 2007

Completion Date:

May 2010

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • recurrent breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201