Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

Exclusion Criteria

• •Age ≥18
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)
• •Adequate bone marrow function (ANC \>1.0 x 109/l, platelets \>100 x 109/l)
• •Adequate hepatic function (ALAT, ASAT and bilirubin \<2 times upper limit of normal)
• •Adequate renal function (creatinine clearance \>60 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
• •Signed written informed consent
• •No previous radiation therapy or chemotherapy
• •No 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.
• •No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
• •No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
• •No concurrent anti-cancer treatment or another investigational drug