99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy

none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.

Inclusion criteria

• Subject is > 18 years of age;
• Diagnosis of primary breast cancer with tumour size ≥ 20 mm and with possible lymph node metastases;
• Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;
• In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme;
• Injection of 99mTc-DARPinG3 at the dosage 3000 µg before and after 2 and 4 courses of chemo+targeted therapy in each HER2-positive breast cancer patient;
• Biopsies should be performed in all patients HER2-positive breast cancer patients before and after 2 and 4 courses of chemo+targeted therapy with evaluation of HER2 expression;
• 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

• 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