erlotinib in treating patients with locally advanced or metastatic breast cancer

Conditions: Breast Cancer

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.

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.

Eligibility 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

Keywords: stage iv breast cancer recurrent breast cancer stage iiib breast cancer male breast cancer