Enrolling by invitation NCT07292571

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

Phase II Interventional Primary Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Injection of [99mTc]Tc-ZHER2:4107, SPECT/CT.
Who it may be relevant to: Registry conditions: Primary Breast Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Russia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Detailed description

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

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

Secondary outcome measures (1)

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Russia · 1 center

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

NCT: NCT07292571 · ORI-15/09/2023-2