An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
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