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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The tested injected doses of [99mTc]Tc-G3-(G3S)3C 3000 μg | Experimental | At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg. Subjects withdrawn from the study for any reason will be replaced. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [99mTc]Tc-G3-(G3S)3C | Drug | One single injection of [99mTc]Tc-G3-(G3S)3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gamma camera-based whole-body [99mTc]Tc-G3-(G3S)3C uptake value (%) | Whole-body [99mTc]Tc-G3-(G3S)3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical | 6 hours |
| SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts | SPECT-based [99mTc]Tc-G3-(G3S)3C uptake value in tumor lesions (counts) [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts | 6 hours |
| SPECT-based [99mTc]Tc-G3-(G3S)3C background uptake value (counts) | Focal uptake of [99mTc]Tc-G3-(G3S)3C in the regions without pathological findings will be assessed with SPECT and measured in counts | 6 hours |
| Tumor-to-background ratio (SPECT) | The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-G3-(G3S)3C uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-G3-(G3S)3C uptake coinciding with the regions without pathological findings (counts) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (vital signs) (% of cases with abnormal findings relative to baseline) | The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline) | 24 hors |
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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 HercepTestâ„¢ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTestâ„¢ 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:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Bragina, Dsc | Tomsk NRMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olga | Tomsk | Russia |
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| Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (physical examination) (% of cases with abnormal findings relative to baseline) |
The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline) |
| 24 hours |
| Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (laboratory tests) (% of cases with abnormal findings relative to baseline) | The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline) | Time Frame: 24 hours |
| Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% of incidence and severity of adverse events) | The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of adverse events (%) | 24 hours |
| Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (ECG ) (% of cases with abnormal findings relative to baseline) | The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline) | 24 hours |
| Safety attributable to [99mTc]Tc-G3-(G3S)3C injections (% concomitant medication) | The safety attributable to [99mTc]Tc-G3-(G3S)3C injections will be evaluated based on the rate of administration of concomitant medication (%) | 24 hours |