An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer

Inclusion criteria: Inclusion Criteria: * Female patients age 18 years or older * Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV); * HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative) * At least one measurable tumour lesion (RECIST); * Availability of tumour samples * Written informed consent that is consistent with ICH-GCP guidelines and local law * Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2. Exclusion criteria: Exclusion Criteria: * Active infectious disease * Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea * Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol * Active/symptomatic brain metastases * Cardiac left ventricular function with resting ejection fraction \< 50% (below upper limit of normal) * ANC less than 1500/mm3 platelet count less than 100 000/mm3 * Bilirubin greater than 1.5 mg /dl (\>26 and#61549 mol /L, SI unit equivalent) * AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases * Serum creatinine greater than 1.5 mg/dl (\>132 and#61549 mol/L, SI unit equivalent) * Patients who are sexually active and unwilling to use a medically acceptable method of contraception * Pregnancy or breast-feeding * Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed * Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol * Active alcohol or drug abuse * Other malignancy within the past 5 years