Clinical Trials Logo
  1. Home
  2. Primary Breast Cancer
  3. NCT04277338

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-HE3-G3 — HE3-G3  

Primary Breast Cancer Clinical Trial

Official title:
SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Designed Ankyrin Repeat Proteins HE3-G3 (99mTc-HE3-G3)

Clinical Trial Summary

The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time; 2. To evaluate dosimetry of 99mTc-HE3-G3; 3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection: The secondary objective are: 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.

Clinical Trial 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-HE3-G3 in patients with primary breast cancer. The study should evaluate distribution of 99mTc-HE3-G3 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are: 1. To assess distribution of 99mTc-HE3-G3 in normal tissues and in tumours over time; 2. To evaluate dosimetry of 99mTc-HE3-G3; 3. To obtain initial information concerning safety and tolerability of 99mTc-HE3-G3 after single intravenous injection: The secondary objective are: 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04277338
Study type Interventional
Source Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact
Status Completed
Phase Phase 1
Start date February 10, 2020
Completion date October 4, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05923177 - Molecular Imaging of HER2 Expression in Breast Cancer Using [123I] I-(HE)3-G3 Phase 1
Completed NCT01033162 - Effectiveness of the CHESS eHealth Cancer Support Intervention in Population-based Care N/A
Recruiting NCT03270007 - Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy Phase 4
Completed NCT00527449 - Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel Phase 2
Completed NCT04468113 - Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy
Recruiting NCT03711877 - Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study) Phase 3
Active, not recruiting NCT01019616 - Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy Phase 3
Completed NCT04127019 - Adjuvant 6 Cycles of Docetaxel and Cyclophosphamide or 3 Cycles of Cyclophosphamide/Epirubicin/Fluorouracil Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Epirubicin and Cyclophosphamide Followed by Weekly Paclitaxel in Operable Breast Cancer (MASTER) Phase 3
Completed NCT01314833 - Minus Anthracycline or Short-Term Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel Regimen for Adjuvant Breast Cancer Therapy Phase 3
Terminated NCT00172068 - Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow Phase 2
Completed NCT01049425 - Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer Phase 3
Recruiting NCT01840293 - Breast Cancer Proteomics and Molecular Heterogeneity
Completed NCT01779479 - Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE) Phase 2
Recruiting NCT05445050 - mULM to Support Breast Cancer Diagnosis and Therapy N/A
Completed NCT00793377 - Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-Doc) Versus Dose-Dense Doxorubicin and Docetaxel (ADoc) in Breast Cancer Phase 3