Status:
COMPLETED
99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborating Sponsors:
Uppsala University
Conditions:
HER2-positive Breast Cancer
Female
Eligibility:
FEMALE
18-80 years
Brief Summary
An open-label, single center study with 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer in dynamic of chemo+targeted therapy, where the primary endpoint of the study...
Detailed Description
none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.
Eligibility Criteria
Inclusion
- Subject is \> 18 years of age;
- Diagnosis of primary breast cancer with tumour size ≥ 20 mm and with possible lymph node metastases;
- 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;
- In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme;
- Injection of 99mTc-DARPinG3 at the dosage 3000 µg before and after 2 and 4 courses of chemo+targeted therapy in each HER2-positive breast cancer patient;
- Biopsies should be performed in all patients HER2-positive breast cancer patients before and after 2 and 4 courses of chemo+targeted therapy with evaluation of HER2 expression;
- 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) 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 :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05412459
Start Date
May 1 2022
End Date
January 31 2023
Last Update
March 6 2023
Active Locations (2)
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1
Tomsk NRMC
Tomsk, Russia
2
TomskNRMC
Tomsk, Russia