Primary Breast Cancer
Conditions
Keywords
Breast Cancer, EpCAm expression, [99mTc]Tc-DARPinEc1-G3C
Brief summary
The study should evaluate distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer. The primary objective are: 1. To assess distribution of \[99mTc\]Tc-DARPinEc1-G3C in normal tissues and in tumors over time; 2. To evaluate dosimetry of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients; 3. To obtain initial information concerning safety and tolerability of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients after single intravenous injection: The secondary objective are: 1\. To compare the tumour imaging data with \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients with Triple negative and Luminal subtypes.
Detailed description
Overall goal of the project: To determine EpCam expression in primary breast cancer before any system therapy. Phase I. Distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary breast cancer. The study should evaluate distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer before treatment. Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
Interventions
DRUG[99mTc]Tc-DARPinEc1-G3C
One single injection of \[99mTc\]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Diagnostic SPECT for EpCam expression in primary breast tumours
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \> 18 years of age 2. Morphological verification of Breast Cancer T2-4N0-3M0-1 3. Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation 4. ECOG 0-2. 5. 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 6. Subject is capable to undergo the diagnostic investigations to be performed in the study 7. Informed consent
Exclusion criteria
1. Refusal from the study 2. Any system/local treatment 3. Second, non-breast malignancy 4. Active current autoimmune/infection disease or history of autoimmune disease. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Pregnancy 7. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor-to-background ratio (SPECT) | 6 hours | The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with the regions without pathological findings (counts) |
| Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent) | 6 hours | Whole-body \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical. |
| SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts) | 6 hours | \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts. |
| SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts) | 6 hours | Focal uptake of \[99mTc\]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of administration of concomitant medication (percent) | 48 hours | The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of administration of concomitant medication (percent) |
| Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline | 48 hours | The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of physical examination (percent of cases with abnormal findings relative to baseline) |
| Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline | 48 hours | The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the assessments of vital signs (percent of cases with abnormal findings relative to baseline) |
| Rate of adverse events (percent) | 48 hours | The safety attributable to \[99mTc\]Tc-DARPinEc1-G3C injections will be evaluated based on the rate of adverse events (percent) |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORVladimir I. Chernov
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Outcome results
None listed