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Primary Breast CancerPhase 1HE3-G3NCT04277338

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3

A Phase 1 study testing SPECT in people with Primary Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time; 2. To evaluate dosimetry of 99mTc-HE3-G3; 3. 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?
SPECT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteRussia
Study dates
10 Feb 2020to 4 Oct 2021
Phase
Phase 1
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

Who may be able to join

  • Subject is > 18 years of age
  • Diagnosis of primary breast cancer with possible lymph node metastases
  • Availability of results from HER2 status previously determined on material from the primary tumor, either
  • HER2-positive, defined as a immunohistochemical test score of 3+ or FISH positive or
  • HER2-negative, defined as a immunohistochemical test score of 0 or 1+; or else if 2+ then FISH negative
  • Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion > 1.0 cm in greatest diameter outside of the liver and kidneys
Show all 15Show fewer
  • Hematological, liver and renal function test results within the following limits:
  • White blood cell count: > 2.0 x 10^9/L
  • Haemoglobin: > 80 g/L
  • Platelets: > 50.0 x 10^9/L
  • Bilirubin =< 2.0 times Upper Limit of Normal
  • Serum creatinine: Within Normal Limits
  • A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening 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)
  • 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.

Russia1 site

  • TomskNRMC

    Tomsk

Other trials in Russia

About this study

Official title: SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins HE3-G3 (99mTc-HE3-G3)

The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer.

The primary objective are:

  1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time;
  2. To evaluate dosimetry of 99mTc-HE3-G3;
  3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection:

The secondary objective are:

1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples.

Read the detailed description

Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.

Phase I. Distribution of 99mTc-HE3-G3 in patients with primary breast cancer. The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer.

The primary objective are:

  1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time;
  2. To evaluate dosimetry of 99mTc-HE3-G3;
  3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection:

The secondary objective are:

  1. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:

Methodology:

Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.

Being tested
SPECT
Keywords
99mTc-HE3-G3, 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.

  • SPECTDrug

    One single injection of 99mTc-HE3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.

Study groups in NCT04277338
Study groupRoleWhat they receive
The tested injected doses of 99mTc-HE3-G3 1000 μgExperimentalAt least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 1000 μg. Subjects withdrawn from the study for any reason will be replaced.
Receives: Drug: SPECT
The tested injected doses of 99mTc-HE3-G3 2000 μgExperimentalAt least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 2000 μg. Subjects withdrawn from the study for any reason will be replaced.
Receives: Drug: SPECT
The tested injected doses of 99mTc-HE3-G3 3000 μgExperimentalAt least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg. Subjects withdrawn from the study for any reason will be replaced.
Receives: Drug: SPECT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gamma camera-based whole-body 99mTc-HE3-G3 uptake value (%)

    Whole-body 99mTc-HE3-G3 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical

    Measured: 6 hours

  2. SPECT-based 99mTc-HE3-G3 uptake value in tumor lesions (counts)

    99mTc-HE3-G3 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

    Measured: 6 hours

  3. SPECT-based 99mTc-HE3-G3background uptake value (counts)

    Focal uptake of 99mTc-HE3-G3 in the regions without pathological findings will be assessed with SPECT and measured in counts

    Measured: 6 hours

  4. Tumor-to-background ratio (SPECT)

    The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-HE3-G3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-HE3-G3 uptake coinciding with the regions without pathological findings (counts)

    Measured: 6 hours

Secondary outcomes (4)

  1. Safety attributable to 99mTc-HE3-G3 injections (physical findings)

    The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (% of cases with abnormal findings relative to baseline)

    Measured: 24 hours

  2. Safety attributable to 99mTc-HE3-G3 injections (laboratory tests)

    The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)

    Measured: 24 hours

  3. Safety attributable to 99mTc-HE3-G3 injections (incidence and severity of adverse events)

    The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the rate of adverse events (%)

    Measured: 24 hours

  4. Safety attributable to 99mTc-HE3-G3 injections (concomitant medication)

    The safety attributable to 99mTc-HE3-G3 injections will be evaluated based on the rate of administration of concomitant medication (%)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start10 Feb 2020
  3. Primary completion10 Feb 2021
  4. Study completion4 Oct 2021

Resources

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 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277338
Sponsor's protocol ID
ORI-08
Acronym
HE3-G3
Status last verified
Jun 2026
First submitted
10 Feb 2020
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bragina O, Chernov V, Schulga A, Konovalova E, Garbukov E, Vorobyeva A, Orlova A, Tashireva L, Sorensen J, Zelchan R, Medvedeva A, Deyev S, Tolmachev V. Phase I Trial of 99mTc-(HE)3-G3, a DARPin-Based Probe for Imaging of HER2 Expression in Breast Cancer. J Nucl Med. 2022 Apr;63(4):528-535. doi: 10.2967/jnumed.121.262542. Epub 2021 Aug 12.

    PubMed 34385343

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPECT 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 15 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: 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Gamma camera-based whole-body 99mTc-HE3-G3 uptake value (%) (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277338, which also lists 1 linked publication.

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.

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