99mTc-DARPinG3 SPECT/CT for Non-invasive HER2-AX in Breast Cancer With Metastatic Lymph Nodes Before Targeted Therapy

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Breast Cancer Female

Treatments: Drug: 99mTc-DARPinG3 SPECT/CT

Study type: Observational

Funder types: Other

Identifiers

NCT05695859

99mTc-DARPinG3 breast cancer

Details and patient eligibility

About

An open-label, single center study with 99mTc-DARPinG3 SPECT/CT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPinG3 SPECT/CT and standard histopathology from relevant tumor and lymph node biopsies.

Full description

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before chemo/targeted therapy.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is > 18 years of age
• Diagnosis of primary breast cancer with lymph node metastases
• 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

Exclusion criteria

• 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) 4. 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