Breast Cancer, Female
Conditions
Keywords
99mTc-ADAPT6, Breast Cancer, metastatic lymph nodes, HER2 expression
Brief summary
An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies.
Detailed description
Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.
Interventions
DRUGADAPT6-SPECT
Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Uppsala University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Diagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \> 18 years of age 2. Diagnosis of primary breast cancer with lymph node metastases 3. 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 4. 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 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 7\. Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions (SUV) | 2 hours | SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV |
| SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes (SUV) | 2 hours | SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes SUV measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV |
| Tumor-to-background ratio (SPECT) | 2 hours | The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV) |
| LN-to-background LN ratio (SPECT) | 2 hours | The SPECT-based LN-to-background LN ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with LN lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Matching test rate (percentage) | 2 hours | Comparison of the 99mTc-ADAPT6 accumulation in the primary tumor and metastatic lymph nodes with the results of morphological and immunohistochemical studies. |
Countries
Russia
Contacts
STUDY_DIRECTORVladimir I Chernov, MD, PhD
Caencer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Outcome results
None listed