Clinical trial NCT05412446: 99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes
Official title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Primary Tumour and Metastatic Axillary Lymph Nodes Using Technetium-99m-labelled ADAPT6 Molecule-based 99mTc-ADAPT6.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Female
Keywords: 99mTc-ADAPT6
Breast Cancer
metastatic lymph nodes
HER2 expression
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2022-06-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Diagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions (SUV)
timeFrame: 2 hours
measure: SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes (SUV)
timeFrame: 2 hours
measure: Tumor-to-background ratio (SPECT)
timeFrame: 2 hours
measure: LN-to-background LN ratio (SPECT)
timeFrame: 2 hours
Secondary outcomes:
measure: Matching test rate (percentage)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk NRMC
Study officials:
affiliation: Caencer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
name: Vladimir I Chernov, MD, PhD
role: STUDY_DIRECTOR
References: