NCT04258735

Genetic Characteristics of Metastatic Breast Cancer Patients

Status unknown NA Last updated 6 February 2020

What this trial tests

NA trial testing Genomic analysis in Metastatic Breast Cancer in 300 participants. Status unknown.

Timeline

17 July 2019

Primary endpoint
31 July 2024

31 July 2024

Quick facts

Lead sponsor	Samsung Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	health services research
Enrollment	300
Start date	17 July 2019
Primary completion	31 July 2024
Estimated completion	31 July 2024
Sites	1 location across South Korea

Drugs / interventions tested

• Genomic analysis

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Samsung Medical Center

Who can join

18 and older, any sex, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Genomic analysis for metastatic breast cancer(MBC) patients

* Participant (Inclusion criteria)

1. Patients who diagnosed metastatic/stage IV breast cancer
2. Patients who were not received treatment for metastatic breast cancer on palliative setting
* Process

(1) Tissue/ Blood sample
* At diagnosis, MBC tissue / blood sample (20cc) will be obtained.
* At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional)

(2) WES, RNASeq, ctDNA, Exosome
* We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
   Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
2. Exosomes: Their Role in Pathogenesis, Diagnosis and Treatment of Diseases.
   Aheget H, Mazini L, Martin F, Belqat B, et al · · 2020 · cited 75× · PMID 33396739 · DOI 10.3390/cancers13010084
3. Exosomes as Emerging Drug Delivery and Diagnostic Modality for Breast Cancer: Recent Advances in Isolation and Application.
   Kumar DN, Chaudhuri A, Aqil F, Dehari D, et al · · 2022 · cited 55× · PMID 35326585 · DOI 10.3390/cancers14061435
4. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
5. Tumor-Derived Extracellular Vesicles: Their Role in Immune Cells and Immunotherapy.
   Li Q, Cai S, Li M, Salma KI, et al · · 2021 · cited 31× · PMID 34408415 · DOI 10.2147/ijn.s313912
6. The Landscape of Exosomes Biogenesis to Clinical Applications.
   Al-Madhagi H. · · 2024 · cited 28× · PMID 38681093 · DOI 10.2147/ijn.s463296
7. The biological function of tumor-derived extracellular vesicles on metabolism.
   Fu X, Song J, Yan W, Downs BM, et al · · 2023 · cited 22× · PMID 37349803 · DOI 10.1186/s12964-023-01111-6
8. Tiny Actors in the Big Cellular World: Extracellular Vesicles Playing Critical Roles in Cancer.
   Jurj A, Pop-Bica C, Slaby O, Ştefan CD, et al · · 2020 · cited 14× · PMID 33080788 · DOI 10.3390/ijms21207688