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Lead
Tomsk National Research Medical Center of the Russian Academy of Sciences
Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy.
Phase I. Distribution of HE3-G3 (\[123I\] I-(HE)3-G3) in patients with primary breast cancer. The study should evaluate distribution of HE3-G3 (\[123I\] I-(HE)3-G3) in patients with primary HER2-positive and HER2-negative breast cancer.
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1. Subject is \> 18 years of age
2. 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
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. 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
5. Subject is capable to undergo the diagnostic investigations to be performed in the study
6. Informed consent
You may not be if
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 (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
5. Administration of other investigational medicinal product within 30 days of screening
6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Clareo Health | Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3
