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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status and phase: Invitation-only; Phase 2

Conditions: Primary Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07292571

HER2 expression level imaging

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

HER2-positive status (IHC 3+)

Experimental group

Description:

Patients with HER2-positive status (IHC 3+)

Treatment:

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

IHC 1+ HER2 expression

Experimental group

Description:

Patients with IHC 1+ HER2 expression

Treatment:

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

IHC 0 HER2 expression

Experimental group

Description:

Patients with IHC 0 HER2 expression

Treatment:

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