Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3

• Status: Recruiting
• Trial end date: 2023-01-21
• Target enrollment: 0
• Participant gender: Female

Summary

An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborator: Uppsala University

Criteria

Inclusion Criteria:

1. Subject is > 18 years of age;

2. Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);

3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;

4. Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;

5. 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

6. 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;

7. Subject is capable to undergo the diagnostic investigations to be performed in the study;

8. Informed consent

Exclusion Criteria:

1. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. 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

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