Clinical trial NCT05412459: 99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy
Official title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients in Dynamic of Chemo+Targeted Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2-positive Breast Cancer
Female
Keywords: 99mTc-DARPinG3
Breast Cancer
HER2 expression
chemotherapy and targeted therapy
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: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer female patients.

Brief summary: An open-label, single center study with 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer in dynamic of chemo+targeted therapy, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPin G3 SPECT and standard histopathology from primary tumor in dynamic of chemo+targeted therapy.

Detailed description: none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.

Eligibility criteria: Inclusion Criteria:

1. Subject is \> 18 years of age;
2. Diagnosis of primary breast cancer with tumour size ≥ 20 mm and with possible lymph node metastases;
3. 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;
4. In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme;
5. Injection of 99mTc-DARPinG3 at the dosage 3000 µg before and after 2 and 4 courses of chemo+targeted therapy in each HER2-positive breast cancer patient;
6. Biopsies should be performed in all patients HER2-positive breast cancer patients before and after 2 and 4 courses of chemo+targeted therapy with evaluation of HER2 expression;
7. 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
8. 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;
9. Subject is capable to undergo the diagnostic investigations to be performed in the study;
10. Informed consent

Exclusion Criteria:

1. Second, non-breast malignancy
2. Active current autoimmune disease or history of autoimmune disease
3. 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
4. Administration of other investigational medicinal product within 30 days of screening
5. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Primary outcomes:
measure: SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor (standardized uptake value (SUV))
timeFrame: 4 hours
measure: SPECT-based tumor-to-background ratio (conventional units)
timeFrame: 4 hours
Secondary outcomes:
measure: Tumor-to-background ratio 99mTc-DARPinG3 SPECT versus immunohistochemical study
timeFrame: 4 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk NRMC
city: Tomsk
country: Russian Federation
facility: TomskNRMC
Study officials:
affiliation: Tomsk NRMC
name: Olga Bragina, MD, Dsc
role: PRINCIPAL_INVESTIGATOR
References: