Status:
COMPLETED
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborating Sponsors:
Uppsala University
Conditions:
Breast Cancer
Female
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief Summary
An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out t...
Detailed Description
Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.
Eligibility Criteria
Inclusion
- 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
- 7\. Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05412446
Start Date
May 1 2022
End Date
December 31 2022
Last Update
April 20 2023
Active Locations (1)
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1
Tomsk NRMC
Tomsk, Russia