[99mTc]Tc-DB8 Accumulation in Primary Tumor in Breast Cancer With Positive and Negative Estrogen Receptor Expression

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status and phase: Invitation-only; Phase 2

Conditions: Primary Breast Cancer

Treatments: Drug: [99mTc]Tc-DB8

Study type: Interventional

Funder types: Other

Identifiers

NCT07275463

Molecular imaging of GRPR

Details and patient eligibility

About

The study should evaluate the [99mTc]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive and negative estrogen receptor expression.

Full description

The aim of the study is to determine gastrin-releasing peptide receptor expression in primary breast cancer patients with positive and negative estrogen receptor expression before any systemic or local treatment.

Phase II. Assessment of [99mTc]Tc-DB8 accumulation in primary tumors with positive and negative estrogen receptor expression in breast cancer patients.

Enrollment: 40 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 estrogen receptor status by Immunohistochemistry previously determined on material from the primary tumor

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) 4. 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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40 participants in 2 patient groups

Breast cancer patients with positive estrogen receptor expression

Experimental group

Description:

Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with positive estrogen receptor expression.

Treatment:

Drug: [99mTc]Tc-DB8

Breast cancer patients with negative estrogen receptor expression

Experimental group

Description:

Assessment of \[99mTc\]Tc-DB8 accumulation in primary tumour of breast cancer patients with negative estrogen receptor expression.

Treatment:

Drug: [99mTc]Tc-DB8