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The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer
Full description
Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy (chemotherapy or/and targeted therapy).
Phase I. Distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.
Enrollment
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Volunteers
Inclusion criteria
Subject is > 18 years of age
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:
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
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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