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An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.
Full description
The primary objectives are:
Compare SPECT/CT imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 in HER2-positive primary tumour of breast cancer patients before system (chemo/targeted) therapy.
The secondary objectives are:
To compare the SPECT/CT tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.
Enrollment
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Inclusion criteria
Subject is > 18 years of age;
Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);
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;
Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;
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;
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Interventional model
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15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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