Clinical trial NCT03991260: 99mTc-ADAPT6-based HER2 Imaging in Breast Cancer
Official title: SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: 99mTc-ADAPT6
Breast Cancer
HER2 expression
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
Collaborators: name: KTH Royal Institute of Technology
name: Uppsala University
First posted: 2019-06-19
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary HER2-positive and HER2-negative breast cancer.

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.

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

Primary outcomes:
measure: Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%)
timeFrame: 6 hours
measure: SPECT-based 99mTc-ADAPT6 uptake value in tumor lesions (kcounts)
timeFrame: 6 hours
measure: SPECT-based 99mTc-ADAPT6 background uptake value (kcounts)
timeFrame: 6 hours
measure: Tumor-to-background ratio (SPECT)
timeFrame: 6 hours
Secondary outcomes:
measure: Safety attributable to 99mTc-ADAPT6 injections (physical findings)
timeFrame: 24 hours
measure: Safety attributable to 99mTc-ADAPT6 injections (laboratory tests)
timeFrame: 24 hours
measure: Safety attributable to 99mTc-ADAPT6 injections (incidence and severity of adverse events)
timeFrame: 24 hours
measure: Safety attributable to 99mTc-ADAPT6 injections (concomitant medication)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: TomskNRMC
Study officials:
affiliation: TomskNMRC
name: Vladimir I Chernov, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: