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Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030537
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: erlotinib hydrochloride Phase 2

Detailed Description:


  • Determine whether a change in epidermal growth factor receptor (EGFR) phosphorylation is detected in tumors of patients with locally advanced or metastatic breast cancer treated with erlotinib.
  • Determine whether a change in other parameters of signal transduction that are downstream of EGFR (ERK and AKT) is detected in tumors of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the response duration and time to progression in patients treated with this drug.
  • Correlate EGFR phosphorylation level with clinical findings and time to progression in patients treated with this drug.
  • Correlate the pharmacokinetics of this drug with a change in EGFR phosphorylation in tumor biopsies of these patients.

OUTLINE: Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed within 4 weeks.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 7-10 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Epidermal Growth Factor Receptor Signaling After Treatment With Oral OSI-774 in Patients With Locally Advanced or Metastatic Breast Cancer
Study Start Date : November 2001
Actual Study Completion Date : March 2003

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the breast

    • Locally advanced or metastatic disease
    • Incurable disease
  • Tumor accessible for biopsy
  • Prior breast cancer allowed
  • No symptomatic or untreated brain metastases or carcinomatous meningitis

    • Neurologically stable patients with inactive brain metastases are allowed if off corticosteroids for at least 4 weeks prior to study
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • ALT/AST no greater than 2.5 times upper limit of normal


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • LVEF at least 40%
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • No prior abnormalities of the cornea, including:

    • Dry eye syndrome or Sjogren's syndrome
    • Congenital abnormality (e.g., Fuch's dystrophy)
    • Abnormal slit-lamp examination with a vital dye (e.g., fluorescein or Bengal-Rose)
    • Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
  • No concurrent use of contact lenses


  • No prior allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib (e.g., gefitinib or other anilinoquinazolines)
  • No other concurrent uncontrolled illness
  • No active infection
  • No uncontrolled diabetes mellitus
  • No psychiatric illness or social situation that would preclude study
  • No untreated life-threatening disease
  • No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • Weight less than 136 kg
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 2 weeks since prior hormonal therapy
  • No concurrent hormonal therapy


  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy except localized external beam radiotherapy for palliative treatment of metastatic disease (cannot include significant cardiac muscle within the radiotherapy field)


  • Not specified


  • No other concurrent investigational anticancer agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030537

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United States, Maryland
Center for Cancer Research
Bethesda, Maryland, United States, 20889-5101
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Antoinette R. Tan, MD National Cancer Institute (NCI)

Publications of Results:
Layout table for additonal information Identifier: NCT00030537    
Obsolete Identifiers: NCT00027313
Other Study ID Numbers: CDR0000069175
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: October 2002
Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
male breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action