Clinical Research Directory

Inclusion Criteria: * Histologically confirmed infiltrating breast cancer * Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions: •\>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+) •HER2 gene amplification defined as \>6 HER2 gene copies per nucleus by in situ hybridization. * Age ≥18 * Eastern Cooperative Oncology Group performance status ≤1 * Adequate bone marrow function (ANC \>1.5 x 109/l, platelets \>100 x 109/l) * Adequate hepatic function (ALAT, ASAT and bilirubin \<2.5 times upper limit of normal) * Adequate renal function (creatinine clearance \>50 ml/min) * LVEF ≥50% measured by echocardiography or MUGA * Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Absence of any medical condition that would place the patient at unusual risk. * Signed written informed consent Exclusion Criteria: * previous radiation therapy or chemotherapy * other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy. * current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection * evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures. * evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast. * concurrent anti-cancer treatment or another investigational drug.