Evaluation of Different Types of HER2 Expression in Breast Cancer Using [99mTc]Tc -ZHER2:4107

NCT07292571 | Enrolling By Invitation Phase 2

• 1 other identifier: HER2 expression level imaging
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study should evaluate the \[99mTc\]Tc -ZHER2:4107 accumulation in primary tumour of breast cancer patients with different HER2 expression

Conditions

Primary Breast Cancer

Keywords

[99mTc]Tc -ZHER2:4107; Breast Cancer; HER2 expression

Outcome Measures

Primary Outcomes (3)

• [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)

  2 hours

• [99mTc]Tc -ZHER2:4107 background uptake

  SPECT-based \[99mTc\]Tc -ZHER2:41 background uptake value (SUVmax)

  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)

  2 hours

Secondary Outcomes (1)

• Differentiation of HER2 expression in primary tumors

  2 hours

Study Arms (3)

HER2-positive status (IHC 3+)

EXPERIMENTAL

Patients with HER2-positive status (IHC 3+)

Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT

IHC 1+ HER2 expression

EXPERIMENTAL

Patients with IHC 1+ HER2 expression

Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT

IHC 0 HER2 expression

EXPERIMENTAL

Patients with IHC 0 HER2 expression

Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT

Interventions

Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT DRUG

One single injection of \[99mTc\]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after injection

Also known as: SPECT/CT Imaging Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107

HER2-positive status (IHC 3+); IHC 0 HER2 expression; IHC 1+ HER2 expression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women with primary breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Cancer Research Institute of Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Vladimir I Chernov, MD, Prof

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 18, 2025
• Study Start: October 20, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)