Genetic Characteristics of Metastatic Breast Cancer Patients

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04258735
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 60.5
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Diagnostic Test: Genomic analysis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Genetic Characteristics of Metastatic Breast Cancer Patients
• Actual Study Start Date: Jul 17, 2019
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Metastatic breast cancer cohort Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome	Diagnostic Test: Genomic analysis; WES, RNASeq, ctDNA, Exosome

Outcome Measures

Primary Outcome Measures

1. Genomic profiling of MBC patients [60 months]

   Gemetic alteration frequency, the association between genetic alteration and survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who diagnosed ad metastatic breast cancer

• Patients who were not received treatment on palliative setting

Exclusion Criteria:

• Patients who did not agree this study

• Patients who did not have any pathologic specimen at MBC diagnosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young-Hyuck Im, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04258735
• Other Study ID Numbers: 2019-05-157
• First Posted: Feb 6, 2020
• Last Update Posted: Feb 6, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 6, 2020