Status:
COMPLETED
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborating Sponsors:
Institute of Bioorganic Chemistry, Russian Academy of Sciences
Uppsala University
Conditions:
Primary Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE1
Brief Summary
The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc-HE3-G3 in...
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 trastuzumab therapy. Phase I. Distribution o...
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 immunohistochemical test score of 3+ or FISH positive or
- HER2-negative, defined as a immunohistochemical test 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 \> 1.0 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 10\^9/L
- Haemoglobin: \> 80 g/L
- Platelets: \> 50.0 x 10\^9/L
- Bilirubin =\< 2.0 times Upper Limit of Normal
- Serum creatinine: Within Normal Limits
- A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening 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 :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04277338
Start Date
February 10 2020
End Date
October 4 2021
Last Update
October 6 2021
Active Locations (1)
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1
TomskNRMC
Tomsk, Russia