Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3

NCT ID: NCT05923177

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-01

Brief Summary

The study should evaluate distribution of [123I] I-(HE)3-G3 in patients with primary HER2-positive and HER2-negative breast cancer

Detailed Description

Overall goal of the project: To determine HER2 expression level in primary breast cancer before neoadjuvant system therapy.

Phase I. Distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary breast cancer. The study should evaluate distribution of HE3-G3 ([123I] I-(HE)3-G3) in patients with primary HER2-positive and HER2-negative breast cancer.

Conditions

Primary Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

The tested injected doses of [123I] I-(HE)3-G3 3000 μg

At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose 3000 μg.

Subjects withdrawn from the study for any reason will be replaced

Group Type: EXPERIMENTAL

SPECT

Intervention Type: DRUG

One single injection of \[123I\] I-(HE)3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.

Interventions

SPECT

One single injection of \[123I\] I-(HE)3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.

Intervention Type: DRUG

Other Intervention Names

[123I] I-(HE)3-G3

Eligibility Criteria

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) 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Bragina, Dsc

Role: PRINCIPAL_INVESTIGATOR

Tomsk NRMC

Locations

TomskNRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

[123I] I-(HE)3-G3

Identifier Type: -

Identifier Source: org_study_id