99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes

Inclusion Criteria

• •1. Subject is \> 18 years of age
• •2. Diagnosis of primary breast cancer with lymph node metastases
• •3. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
• •4. Hematological, liver and renal function test results within the following limits:
• •* White blood cell count: \> 2.0 x 109/L
• •* Hemoglobin: \> 80 g/L
• •* Platelets: \> 50.0 x 109/L
• •* ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
• •* Bilirubin =\< 2.0 times Upper Limit of Normal
• •* Serum creatinine: Within Normal Limits
• •5. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
• •7\. Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent