99mTc-ADAPT6-based HER2 Imaging in Breast Cancer

NCT ID: NCT03991260

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2020-09-05

Brief Summary

The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.

The primary objective are:

1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;

2. To assess kinetics of 99mTc- ADAPT6 in blood;

3. To evaluate dosimetry of 99mTc- ADAPT6;

4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:

The secondary objective is:

1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:

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 of 99mTc-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.

The primary objective are:

1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;

2. To assess kinetics of 99mTc- ADAPT6 in blood;

3. To evaluate dosimetry of 99mTc- ADAPT6;

4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:

The secondary objective is:

1. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:

Methodology:

Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.

Conditions

Breast Cancer

Study Design

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

Study Groups

The tested injected doses of 99mTc- ADAPT6 500 µg

At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 500 µg. Subjects withdrawn from the study for any reason will be replaced.

SPECT

Intervention Type: DIAGNOSTIC_TEST

One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.

The tested injected doses of 99mTc- ADAPT6 1000 µg

At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 1000 µg. Subjects withdrawn from the study for any reason will be replaced.

SPECT

Intervention Type: DIAGNOSTIC_TEST

One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.

Interventions

SPECT

One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Subject is > 18 years of age

2. Diagnosis of primary breast cancer with possible lymph node metastases

3. Availability of results from HER2 status previously determined on material from the primary tumor, either

1. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or

2. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative

4. 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

5. 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
• ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
• Bilirubin =< 2.0 times Upper Limit of Normal
• Serum creatinine: Within Normal Limits

6. 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

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

11. 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

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

6. 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

KTH Royal Institute of Technology

OTHER

Sponsor Role: collaborator

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

Vladimir I Chernov, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

TomskNMRC

Locations

TomskNRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

99mTc-ADAPT6 [TomskNRMC]

Identifier Type: OTHER

Identifier Source: secondary_id

99mTc-ADAPT6

Identifier Type: -

Identifier Source: org_study_id