Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal ALT/AST no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 40% No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Ophthalmic: 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 Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: 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 Radiotherapy: 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) Surgery: Not specified Other: No other concurrent investigational anticancer agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erlotinib hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, male breast cancer