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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Breast Cancer
• Intervention / Treatment: Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT

Detailed Description

To determine different HER2 expression in primary breast cancer patients before any system or local treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is > 18 years of age
2. 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

3. 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
4. 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
5. Subject is capable to undergo the diagnostic investigations to be performed in the study
6. Informed consent

Exclusion Criteria:

1. Any system therapy (chemo-/targeted therapy)
2. Second, non-breast malignancy
3. Active current autoimmune disease or history of autoimmune disease
4. 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
5. Administration of other investigational medicinal product within 30 days of screening
6. Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HER2-positive status (IHC 3+); Patients with HER2-positive status (IHC 3+)	Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT; One single injection of [99mTc]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after injection; Other Names: SPECT/CT Imaging Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107
Experimental: IHC 1+ HER2 expression; Patients with IHC 1+ HER2 expression	Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT; One single injection of [99mTc]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after injection; Other Names: SPECT/CT Imaging Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107
Experimental: IHC 0 HER2 expression; Patients with IHC 0 HER2 expression	Drug: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT; One single injection of [99mTc]Tc-ZHER2:4107, followed by SPECT/CT imaging 2 hours after injection; Other Names: SPECT/CT Imaging Using Technetium-99m-labelled Affibody [99mTc]Tc -ZHER2:4107

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Vladimir I Chernov, MD, Prof, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; HER2 expression; [99mTc]Tc -ZHER2:4107
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: HER2 expression level imaging

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No