Taxanes and anthracyclines. considering Androgen Receptor Antagonists the safety and efficacy in cancer neratinib ErbB2 overexpressing breast cancer observed, we tried to intwocohorts clinical activity of t positive breast cancer in patients with advanced ErbB2 cohort in the Sch Tzung exposure to trastuzumab against trastuzumab and the other untreated. Patients and Methods Patients eligible women were18 years of stage IIIB, IIIC or IV breast cancer was not curable with treatment available. The detection of erbB2 gene amplification in the tumor tissue, as measured by fluorescence in situ hybridization of an independent Ngigen assessment was necessary. Patients were also required to have measurable disease by response evaluation criteria in solid tumors modified, a 11 Eastern Cooperative Oncology Group performance status 0-2 and adequate hours Dermatological, hepatic defined, and renal function. Patients had k Nnten have four or fewer prior cytotoxic chemotherapy for metastatic disease or relapse confinement Lich anthracyclines Descr Nkt at a cumulative dose of more than 400 mg/m2 of doxorubicin or equivalent. Before chemotherapy, radiation therapy, cancer treatment of others, including trastuzumab, or a gr Eren operation must be completed within 1 week after the first dose of neratinib. The main exclusion criteria were active central nervous system disease, a history of clinically significant cardiac disease or uncontrolled EEA or baseline left ventricular Ren ejection fraction below 50%. Two cohorts of patients were enrolled. Patients in cohort A had prior treatment with trastuzumab in the progression after at least 6 weeks of trastuzumab to standard doses of defined metastatic or locally advanced or progression on or after adjuvant therapy has trastuzumabcontaining patients in cohort B n again u no prior treatment with trastuzumab. The study was institutional review boards or independent Approved Independent Ethics Committees of participating centers and all patients written informed Einverst Gave ndnis. The study was conducted in accordance with the International Conference on Harmonisation guidelines for good clinical practice, the Declaration of Helsinki and performed with the applicable rules and Locational laws. Study Design This was an open-label Phase II conducted in 28 study centers worldwide. The prime Re endpoint was the rate of 16 weeks, the progression-free survival of the evaluable population than by an independent Judged Independent verification. Secondary Re endpoints included safety, objective response rate, clinical benefit rate, duration of response and evaluation of the pharmacokinetics neratinib. Objective response was defined as the percentage of patients who completely Requests reference requests getting or partial remission had. The clinical benefit had been defined as the percentage of patients who completely Requests reference requests getting or partial response or stable disease for at least 24 weeks. The administration of treatment, patients were instructed to neratinib neratinib 240 mg once t Possible with food, preferably in the morning. Although the dose-escalation part of the proposed Phase I trial that 320mgadministered oral dose once t Resembled themaximumtolerated have had more clinical experience unacceptably high rates of diarrhea demonstrated at this dose is 240 mg orally once t Was possible for the phase II development selected hlt. Neratinib continue treatment if they were WEL.