CompletedPhase 2

99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes

Russia30 participantsStarted 2022-05-01

Plain-language summary

An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is \> 18 years of age
✓. Diagnosis of primary breast cancer with lymph node metastases
✓. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
✓. Hematological, liver and renal function test results within the following 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

Exclusion criteria

✕. Any system therapy (chemo-/targeted therapy)
✕. 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

What they're measuring

SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions (SUV)

Timeframe: 2 hours

SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes (SUV)

Timeframe: 2 hours

Tumor-to-background ratio (SPECT)

Timeframe: 2 hours

LN-to-background LN ratio (SPECT)

Timeframe: 2 hours

Trial details

NCT IDNCT05412446

SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is \> 18 years of age
✓. Diagnosis of primary breast cancer with lymph node metastases
✓. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
✓. Hematological, liver and renal function test results within the following 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

Exclusion criteria

✕. Any system therapy (chemo-/targeted therapy)
✕. 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