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Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2
Bu çalışma, HER2 proteinini aşırı ifade eden ileri evre veya metastatik meme kanseri (breast cancer) olan hastalarda lapatinib ditosylate ilacını incelemektedir. Çalışmaya, HER2 pozitifliği doğrulanmış, ölçülebilir veya değerlendirilebilir hastalığı olan kadın hastalar katılabilmiş ve biyobelirteç analizi için tümör biyopsileri alınmıştır. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Advanced or metastatic disease * No effective curative therapy available * Bone-only disease allowed * Tumor HER2 overexpression * HER2 3+ expression by immunohistochemistry OR \> 2-fold (HER2 2+) gene amplification by fluorescence in situ hybridization * Evaluable disease * Measurable disease is not required * No progressive brain metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * Life expectancy \> 3 months * Female * Menopausal status not specified * Absolute neutrophil count ≥ 1,000 cells/mm\^3 * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 75,000 cells/mm\^3 * Total bilirubin normal * AST and ALT ≤ 3 x upper limits of normal (ULN) (≤ 5 x ULN with liver metastases) * Creatinine normal OR creatinine clearance ≥ 40 mL/min * INR ≤ 1.5 * Potassium normal * Magnesium normal * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception prior to and during study therapy * Cardiac ejection fraction ≥ 50% * Consents to 2 tumor fine needle aspiration biopsies for biomarker analysis * Lung-only disease or sites otherwise deemed high-risk for biopsy, the requirement for biopsy will be waived Exclusion criteria: * History of significant cardiac disease including any of the following: * Congestive heart failure * Symptomatic cardiac arrhythmias * Unstable angina * Uncontrolled prior lapatinib ditosylate therapy toxicity ≥ grade 2 * Allergic reactions to IV contrast dye despite standard prophylaxis * History of malabsorption syndrome or disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism, or excretion of study drug * Conditions that would impair the patient's ability to swallow and retain oral medication * Concurrent disease or condition that would make the patient inappropriate for study participation or would interfere with the patient's safety * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol PRIOR CONCURRENT THERAPY: * Prior lapatinib ditosylate or trastuzumab allowed * At least 4 weeks since prior and no concurrent chemotherapy or investigational anticancer agents * At least 2 weeks since prior and no concurrent hormonal therapy * At least 2 weeks since prior and no concurrent lapatinib ditosylate prohibited medications, including CYP3A4 inhibitors or inducers, all herbal supplements, and gastric pH modifiers * More than 4 weeks since prior radiotherapy * No aspirin or plavix therapy within 7 days prior to tumor biopsy * No concurrent coumadin * Low molecular weight heparin allowed provided it can be held at least 24 hours prior to tumor biopsy * Concurrent gonadal suppression agents (i.e., Zoladex or Lupron) or palliative bisphosphonates (i.e., Zometa) allowed