PET Study of Breast Cancer Patients Using [68Ga]ABY-025

Inclusion Criteria

• •1. Subject is \> 18 years of age
• •2. Diagnosis of invasive breast cancer with 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 metastasis lesions on CT or MRI, with at least one lesion \>= 10 mm in smallest diameter and suitable for biopsy
• •5. ECOG performance status of =\< 2
• •6. Life expectancy of at least 12 weeks
• •7. Hematological, liver and renal function test results within the following limits:
• •White blood cell count: \> 2.0 x 10\^9/L Haemoglobin: \> 80 g/L Platelets: \> 50.0 x 10\^9/L ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal Bilirubin =\< 2.0 times Upper Limit of Normal Serum creatinine: Within Normal Limits or else normal clearance
• •8. A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all female patients of childbearing potential, who must use a medically acceptable form of contraception from study start until at least 30 days after study termination
• •9. Subject is able to participate in the diagnostic investigations to be performed in the study
• •10. Informed consent