Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

Trial Title: Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy

NCT ID: NCT05923268

Condition: Breast Cancer Female

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: [99mTc]Tc-G3-(G3S)3C
Description: One single injection of [99mTc]Tc-G3-(G3S)3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours
Arm group label: The tested injected doses of [99mTc]Tc-G3-(G3S)3C 3000 μg

Summary: The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C 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 (chemotherapy or/and targeted therapy). Phase I. Distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary breast cancer. The study should evaluate distribution of [99mTc]Tc-G3-(G3S)3C in patients with primary HER2-positive and HER2-negative breast cancer.

Criteria for 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

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Olga

Address:
City: Tomsk
Country: Russian Federation

Start date: June 4, 2023

Completion date: June 15, 2024

Lead sponsor:
Agency: Tomsk National Research Medical Center of the Russian Academy of Sciences
Agency class: Other

Source: Tomsk National Research Medical Center of the Russian Academy of Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05923268