99mTc-DARPinG3-based HER2 Expression Molecular Imaging in HER2-positive Breast Cancer During Chemo+Targeted Therapy

HER2-positive Breast Cancer Clinical Trial

Official title:

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients in Dynamic of Chemo+Targeted Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05412459
• Other study ID #: 99mTc-DARPinG3
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2022
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 is to find out the correlation between the HER2 expression measured by 99mTc-DARPin G3 SPECT and standard histopathology from primary tumor in dynamic of chemo+targeted therapy.

Description:

none Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject is > 18 years of age;

2. Diagnosis of primary breast cancer with tumour size = 20 mm and with possible lymph node metastases;

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. In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme;

5. 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;

6. 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;

7. 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

8. 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;

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

10. 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

4. Administration of other investigational medicinal product within 30 days of screening

5. Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Related Conditions & MeSH terms

• Breast Neoplasms
• Female
• HER2-positive Breast Cancer

Intervention

Drug:
• 99mTc-DARPinG3
Diagnostic test (99mTc-DARPinG3-based SPECT) is used for the assessment of the effect of anticancer therapy.

Locations

Country	Name	City	State
Russian Federation	Tomsk NRMC	Tomsk
Russian Federation	TomskNRMC	Tomsk

Sponsors (2)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor (standardized uptake value (SUV))	SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor lesions (SUV) of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV before and after 2 and 4 courses of chemo+targeted therapy	4 hours
Primary	SPECT-based tumor-to-background ratio (conventional units)	The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with primary tumor lesions (SUV) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (SUV) before and after 2 and 4 courses of chemo+targeted therapy	4 hours
Secondary	Tumor-to-background ratio 99mTc-DARPinG3 SPECT versus immunohistochemical study	Comparison of the 99mTc-DARPinG3 accumulation (SUV or count-to-background ratio) in primary tumour with the results of morphological and immunohistochemical studies (score from 1 to 3) before and after 2 and 4 courses of chemo+targeted therapy	4 hours