Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.~Phase I. Distribution of 99mTc-ZHER2:41071 in patients with primary breast cancer.~The study should evaluate distribution of 99mTc-ZHER2:41071 in patients with primary HER2-positive and HER2-negative breast cancer.~The primary objectives are:~To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;~To evaluate dosimetry of 99mTc-ZHER2:41071;~To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:~The secondary objectives are:~1. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) analysis of biopsy samples:~Methodology:~Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer~The primary objectives are:~To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;~To evaluate dosimetry of 99mTc-ZHER2:41071;~To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:~The secondary objectives are:~1. To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.