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

SPECT/CT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Primary Tumour and Metastatic Axillary Lymph Nodes Using Technetium-99m-labelled DARPinG3 Molecule-based.

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.

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before chemo/targeted therapy.

Inclusion Criteria:

• Subject is > 18 years of age
• Diagnosis of primary breast cancer with lymph node metastases
• 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
• 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.
• 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
• Subject is capable to undergo the diagnostic investigations to be performed in the study
• Informed consent

Exclusion Criteria:

• Any system therapy (chemo-/targeted therapy)
• Second, non-breast malignancy
• Active current autoimmune disease or history of autoimmune disease
• Active 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 C
• Administration of other investigational medicinal product within 30 days of screening
• Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's