99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy

NCT05412459 | Completed

• 1 other identifier: ORI-04/03/2022-3
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

HER2-positive Breast Cancer; Female

Keywords

99mTc-DARPinG3; Breast Cancer; HER2 expression; chemotherapy and targeted therapy

Outcome Measures

Primary Outcomes (2)

• SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor (standardized uptake value (SUV))

  SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor lesions (SUV) of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV before and after 2 and 4 courses of chemo+targeted therapy

  4 hours

• SPECT-based tumor-to-background ratio (conventional units)

  The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with primary tumor lesions (SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (SUV) before and after 2 and 4 courses of chemo+targeted therapy

  4 hours

Secondary Outcomes (1)

• Tumor-to-background ratio 99mTc-DARPinG3 SPECT versus immunohistochemical study

  4 hours

Study Arms (1)

The tested injected doses of 99mTc-DARPinG3 3000 μg (SPECT)

Maximum (15) evaluable subjects with HER2-positive status in primary tumour before, after 2 and 4 courses of chemo+targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced.

Drug: 99mTc-DARPinG3

Interventions

99mTc-DARPinG3 DRUG

Diagnostic test (99mTc-DARPinG3-based SPECT) is used for the assessment of the effect of anticancer therapy.

Also known as: Diagnostic injection of 99mTc-DARPinG3.

The tested injected doses of 99mTc-DARPinG3 3000 μg (SPECT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer female patients.

You may qualify if:

• Subject is \> 18 years of age;
• Diagnosis of primary breast cancer with tumour size ≥ 20 mm and with possible lymph node metastases;
• 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;
• In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme;
• 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;
• 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;
• 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
• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead
• Uppsala University: collaborator

Study Sites (2)

Tomsk NRMC

Tomsk, Russia

Location

TomskNRMC

Tomsk, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biopsies.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olga Bragina, MD, Dsc

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 9, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

RU (2)