Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.~Phase I. Distribution of 99mTc-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.~The primary objective are:~To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;~To assess kinetics of 99mTc- ADAPT6 in blood;~To evaluate dosimetry of 99mTc- ADAPT6;~To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:~The secondary objective is:~1. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:~Methodology:~Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.
The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.~The primary objective are:~To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;~To assess kinetics of 99mTc- ADAPT6 in blood;~To evaluate dosimetry of 99mTc- ADAPT6;~To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:~The secondary objective is:~1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples: