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

NCT ID: NCT05695859

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2023-12-01

Brief Summary

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.

Detailed Description

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

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

99mTc-DARPinG3 SPECT/CT

One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection

Intervention Type: DRUG

Other Intervention Names

SPECT/CT

Eligibility Criteria

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

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

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir Chernov, MD

Role: PRINCIPAL_INVESTIGATOR

Tomsk NRMC

Locations

Russia Tomsk NRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

99mTc-DARPinG3 breast cancer

Identifier Type: -

Identifier Source: org_study_id