Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

Inclusion Criteria:

1. Subject is > 18 years of age

2. Availability of results from HER2 status previously determined on material from theprimary tumor and metastatic LN, either a. HER2-positive, defined as a DAKOHercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKOHercepTest™ score of 0 or 1+; or else if 2+ then FISH negative

3. 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

4. A negative pregnancy test for all patients of childbearing potential. Sexuallyactive women of childbearing potential participating in the study must use amedically acceptable form of contraception for at least 30 days after studytermination

5. Subject is capable to undergo the diagnostic investigations to be performed in thestudy

6. Informed consent

Exclusion Criteria:

1. Any system therapy (chemo-/targeted therapy)

2. Second, non-breast malignancy

3. Active current autoimmune disease or history of autoimmune disease

4. Active infection or history of severe infection within the previous 3 months (ifclinically relevant at screening) 4. Known HIV positive or chronically activehepatitis B or C

5. Administration of other investigational medicinal product within 30 days ofscreening

6. Ongoing toxicity > grade 2 from previous standard or investigational therapies,according to US National Cancer Institute's