Evaluation of Different Types of HER2 Expression in Breast Cancer Using [99mTc]Tc -ZHER2:4107
NCT ID: NCT07292571
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
50 participants
INTERVENTIONAL
2025-10-20
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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HER2-positive status (IHC 3+)
Patients with HER2-positive status (IHC 3+)
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
IHC 1+ HER2 expression
Patients with IHC 1+ HER2 expression
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
IHC 0 HER2 expression
Patients with IHC 0 HER2 expression
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
FEMALE
No
Sponsors
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Uppsala University
OTHER
Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Vladimir I Chernov, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Tomsk NRMC
Locations
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Cancer Research Institute of Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, , Russia
Countries
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Other Identifiers
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HER2 expression level imaging
Identifier Type: -
Identifier Source: org_study_id