Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer

Exclusion Criteria

• •Pregnant or lactating women
• •Concurrent participation in another clinical trial. Prior participation is allowed if the last study medication was administered more than 4 weeks prior to randomization
• •Asymptomatic with regards to tumor illness
• •Previous treatment with lapatinib, capecitabine or vinorelbine
• •Necessity of planned treatment with other chemotherapeutics oder anti-hormone therapy
• •Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
• •Evidence of cardiovascular disease, e.g. myocardial infection, unstable angina pectoris or arrhythmia
• •History of vascular or cardiovascular disease within the past 6 months
• •All illnesses that result in malabsorption of oral medication or inability to take oral medication
• •Concurrent treatment with anti-viral drugs based on sorivudine or with aminoglycosides
• •Concurrent treatment with any drug interfering with study medication, especially, those that induce CYP3A
• •Concurrent treatment with allopurinol
• •Other malignancies (except for basal cell carcinoma of the skin and cervical carcinoma in situ); patient can be included in the study if no recurrent disease has been observed for at least 5 years
• •Concurrent illnesses or other circumstances that could interfere with trial participation, efficacy or safety of the patient