99mTc-DARPinG3 SPECT/CT for Non-invasive HER2-AX in Breast Cancer With Metastatic Lymph Nodes Before Targeted Therapy

An open-label, single center study with 99mTc-DARPinG3 SPECT/CT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPinG3 SPECT/CT and standard histopathology from relevant tumor and lymph node biopsies.

Inclusion Criteria:Subject is > 18 years of ageDiagnosis of primary breast cancer with lymph node metastasesAvailability 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 negativeHematological, 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.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 terminationSubject is capable to undergo the diagnostic investigations to be performed in the studyInformed consentExclusion Criteria:Any system therapy (chemo-/targeted therapy)Second, non-breast malignancyActive current autoimmune disease or history of autoimmune diseaseActive infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or CAdministration of other investigational medicinal product within 30 days of screeningOngoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's