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

NCT ID: NCT05412459

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-01-31

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 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.

Detailed Description

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

Conditions

HER2-positive Breast Cancer; Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The tested injected doses of 99mTc-DARPinG3 3000 μg (SPECT)

Maximum (15) evaluable subjects with HER2-positive status in primary tumour before, after 2 and 4 courses of chemo+targeted therapy have to be enrolled in the study.

Subjects withdrawn from the study for any reason will be replaced.

99mTc-DARPinG3

Intervention Type: DRUG

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

Interventions

99mTc-DARPinG3

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

Intervention Type: DRUG

Other Intervention Names

Diagnostic injection of 99mTc-DARPinG3.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Bragina, MD, Dsc

Role: PRINCIPAL_INVESTIGATOR

Tomsk NRMC

Locations

Tomsk NRMC

Tomsk, , Russia

TomskNRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

99mTc-DARPinG3

Identifier Type: -

Identifier Source: org_study_id