Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

Inclusion Criteria

• •1. Subject is \> 18 years of age
• •2. Diagnosis of primary breast cancer with possible lymph node metastases
• •3. Availability of results from HER2 status previously determined on material from the primary tumor, either
• •1. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
• •2. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
• •4. Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion \> 2.0 cm in greatest diameter outside of the liver and kidneys
• •5. 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
• •6. 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