* \>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of \>2.2. or as \>5 HER2 gene copies per nucleus in CISH analysis.
You may not be if
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
Clareo Health | Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study
