HER2-positive Breast CancerNCT05412459
99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy
An observational study of HER2-positive Breast Cancer and Female, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 2 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Female
- What is being tested?
- 99mTc-DARPinG3
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 2 sitesRussia
- Study dates
- 1 May 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer female patients.
Who may be able to join
- 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;
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- 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;
- Informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the detailed description
none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
- Conditions
- HER2-positive Breast Cancer, Female
- Being tested
- 99mTc-DARPinG3
- Keywords
- 99mTc-DARPinG3, Breast Cancer, HER2 expression, chemotherapy and targeted therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-DARPinG3Drug
Also called Diagnostic injection of 99mTc-DARPinG3.
Diagnostic test (99mTc-DARPinG3-based SPECT) is used for the assessment of the effect of anticancer therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 99mTc-DARPinG3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 hours
Secondary outcomes (1)
Tumor-to-background ratio 99mTc-DARPinG3 SPECT versus immunohistochemical study
Comparison of the 99mTc-DARPinG3 accumulation (SUV or count-to-background ratio) in primary tumour with the results of morphological and immunohistochemical studies (score from 1 to 3) before and after 2 and 4 courses of chemo+targeted therapy
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 May 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
- Investigators
- Olga Bragina, MD, Dsc, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412459
- Sponsor's protocol ID
- ORI-04/03/2022-3
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05412459
- Acronym / sponsor ID
- ORI-04/03/2022-3
- Conditions
- HER2-positive Breast Cancer, Female
- Keywords
- 99mTc-DARPinG3, Breast Cancer, HER2 expression, chemotherapy and targeted therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The tested injected doses of 99mTc-DARPinG3 3000 μg (SPECT) | – | Drug: 99mTc-DARPinG3Maximum (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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer female patients.
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-DARPinG3Also: Diagnostic injection of 99mTc-DARPinG3.Diagnostic test (99mTc-DARPinG3-based SPECT) is used for the assessment of the effect of anticancer therapy. | Drug | The tested injected doses of 99mTc-DARPinG3 3000 μg (SPECT) |
Primary outcome
SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor (standardized uptake value (SUV))
Time frame: 4 hours
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
SPECT-based tumor-to-background ratio (conventional units)
Time frame: 4 hours
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
1 secondary outcome
Tumor-to-background ratio 99mTc-DARPinG3 SPECT versus immunohistochemical study
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Bragina, MD, Dsc principal investigator
Tomsk NRMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer and Female, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor (standardized uptake value (SUV)) (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.