Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
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
