Tipifarnib Plus Trastuzumab in Treating Patients With Metastatic Breast Cancer
Breast Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, male breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic adenocarcinoma of the breast HER2/neu 3+ by immunohistochemical staining 2+ eligible provided HER2/neu positive by fluorescent in-situ hybridization (FISH) HER2/neu positive by FISH alone allowed Unidimensionally measurable disease At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Must have received prior trastuzumab (Herceptin) Patients with known brain metastases meeting any of the following criteria are not eligible: Require high-dose steroid therapy or enzyme-inducing anticonvulsant drugs No prior cranial radiotherapy Have progressive neurologic dysfunction that would preclude study evaluation Have evidence of progressive CNS disease by CT scan or MRI Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Over 18 Sex Male or female Menopausal status Not specified Performance status ECOG 0-2 OR Karnofsky 70-100% Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Ejection fraction greater than 50% by MUGA or echocardiogram Gastrointestinal No gastrointestinal tract disease resulting in an inability to tolerate oral medication No requirement for IV alimentation No active peptic ulcer disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant traumatic injury within the past 21 days No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No ongoing or active infection No prior allergic reaction attributed to compounds of similar chemical or biological composition to tipifarnib (e.g., quinolones) or trastuzumab No psychiatric illness or social situation that would preclude study compliance No other concurrent medical illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior bone marrow transplantation with high-dose chemotherapy No concurrent immunotherapy Chemotherapy See Biologic therapy No more than 2 prior chemotherapy regimens for metastatic disease More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Prior combination chemotherapy allowed No concurrent chemotherapy Endocrine therapy See Disease Characteristics Prior hormonal therapy allowed No concurrent hormonal therapy for cancer Radiotherapy See Disease Characteristics More than 4 weeks since prior wide-field radiotherapy and recovered No concurrent radiotherapy Surgery Prior modified radical mastectomy or lumpectomy with axillary node dissection allowed Prior resection of metastatic lesions allowed More than 21 days since prior major surgery No prior surgery affecting absorption Other No prior tipifarnib More than 6 weeks since initiation of bisphosphonate therapy (if bone lesions are the only site of measurable disease) Bisphosphonate therapy may not be initiated during study No other concurrent investigational agents No other concurrent anticancer therapy No concurrent antacids within 2 hours of study drug