Primary Breast CancerPhase 2NCT07292571
Evaluation of Different Types of HER2 Expression in Breast Cancer Using [99mTc]Tc -ZHER2:4107
A Phase 2 study testing Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT in people with Primary Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The study should evaluate the [99mTc]Tc -ZHER2:4107 accumulation in primary tumour of breast cancer patients with different HER2 expression Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 20 Oct 2025to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subject is > 18 years of age
- 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
- 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
Show all 12Show fewer
- 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
- Any system therapy (chemo-/targeted therapy)
- 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), 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Cancer Research Institute of Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk
About this study
Official title: SPECT/CT Imaging of Different Types of HER2 Expression in Breast Cancer Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107
The study should evaluate the [99mTc]Tc -ZHER2:4107 accumulation in primary tumour of breast cancer patients with different HER2 expression
Read the detailed description
To determine different HER2 expression in primary breast cancer patients before any system or local treatment.
- Conditions
- Primary Breast Cancer
- Being tested
- Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT
- Keywords
- [99mTc]Tc -ZHER2:4107, Breast Cancer, HER2 expression
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of [99mTc]Tc-ZHER2:4107, SPECT/CTDrug
Also called SPECT/CT Imaging Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107
One single injection of [99mTc]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after injection
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive status (IHC 3+) | Experimental | Patients with HER2-positive status (IHC 3+) Receives: Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT |
| IHC 1+ HER2 expression | Experimental | Patients with IHC 1+ HER2 expression Receives: Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT |
| IHC 0 HER2 expression | Experimental | Patients with IHC 0 HER2 expression Receives: Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
[99mTc]Tc -ZHER2:4107 uptake in primary breast tumor
SPECT/СT-based [99mTc]Tc -ZHER2:4107 uptake in primary breast tumor with different HER2 expression (SUVmax)
Measured: 2 hours
[99mTc]Tc -ZHER2:4107 background uptake
SPECT-based [99mTc]Tc -ZHER2:41 background uptake value (SUVmax)
Measured: 2 hours
Tumor-to-background ratio
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc -ZHER2:41 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc -ZHER2:41 uptake coinciding with the regions without pathological findings (SUVmax)
Measured: 2 hours
Secondary outcomes (1)
Differentiation of HER2 expression in primary tumors
To evaluate the threshold values of [99mTc]Tc -ZHER2:4107 accumulation for differentiation of HER2 expression in primary tumors in breast cancer patients
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start20 Oct 2025
- Primary completion30 Mar 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
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
- Vladimir I Chernov, MD, Prof, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292571
- Sponsor's protocol ID
- ORI-15/09/2023-2
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
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/CT Imaging of Different Types of HER2 Expression in Breast Cancer Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107
- ClinicalTrials.gov ID
- NCT07292571
- Acronym / sponsor ID
- ORI-15/09/2023-2
- Conditions
- Primary Breast Cancer
- Keywords
- [99mTc]Tc -ZHER2:4107, Breast Cancer, HER2 expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
The study should evaluate the [99mTc]Tc -ZHER2:4107 accumulation in primary tumour of breast cancer patients with different HER2 expression
Detailed description
To determine different HER2 expression in primary breast cancer patients before any system or local treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HER2-positive status (IHC 3+) | Experimental | Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CTPatients with HER2-positive status (IHC 3+) |
| IHC 1+ HER2 expression | Experimental | Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CTPatients with IHC 1+ HER2 expression |
| IHC 0 HER2 expression | Experimental | Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CTPatients with IHC 0 HER2 expression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is > 18 years of age
- 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
- Hematological, liver and renal function test results within the following 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
Key exclusion criteria (6 listed)
- Any system therapy (chemo-/targeted therapy)
- 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), known HIV positive or chronically active hepatitis B or C
- Administration of other investigational medicinal product within 30 days of screening
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 |
|---|---|---|
| Injection of [99mTc]Tc-ZHER2:4107, SPECT/CTAlso: SPECT/CT Imaging Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107One single injection of [99mTc]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after injection | Drug | HER2-positive status (IHC 3+), IHC 0 HER2 expression, IHC 1+ HER2 expression |
Primary outcome
[99mTc]Tc -ZHER2:4107 uptake in primary breast tumor
Time frame: 2 hours
SPECT/СT-based [99mTc]Tc -ZHER2:4107 uptake in primary breast tumor with different HER2 expression (SUVmax)
[99mTc]Tc -ZHER2:4107 background uptake
Time frame: 2 hours
SPECT-based [99mTc]Tc -ZHER2:41 background uptake value (SUVmax)
Tumor-to-background ratio
Time frame: 2 hours
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc -ZHER2:41 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc -ZHER2:41 uptake coinciding with the regions without pathological findings (SUVmax)
1 secondary outcome
Differentiation of HER2 expression in primary tumors
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
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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.
Vladimir I Chernov, MD, Prof principal investigator
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT in people with Primary Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site 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 12 inclusion and 6 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: enrolling by invitation, 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 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
[99mTc]Tc -ZHER2:4107 uptake in primary breast tumor (time frame: 2 hours). The study lists 3 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.