Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, male breast cancer
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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Countries
United States