Status:
COMPLETED
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-80 years
Phase:
PHASE1
Brief Summary
The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer The primary objectives are: 1. To assess distribu...
Detailed Description
Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzum...
Eligibility Criteria
Inclusion
- Subject is \> 18 years of age
- Diagnosis of primary breast cancer with possible lymph node metastases
- Availability of results from HER2 status previously determined on material from the primary tumor, either
- HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
- HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
- Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion \> 2.0 cm in greatest diameter outside of the liver and kidneys
- 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
- 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)
- 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 :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05203497
Start Date
December 22 2021
End Date
March 1 2023
Last Update
April 21 2023
Active Locations (1)
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1
TomskNRMC
Tomsk, Russia