NCT06330870

Brief Summary

This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
20mo left

Started Apr 2023

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Dec 2027

Study Start

First participant enrolled

April 6, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

February 6, 2024

Last Update Submit

March 19, 2024

Conditions

Breast CancerBrain Metastasis

Outcome Measures

Primary Outcomes (1)

  • Intracranial disease free survival

    Time to new brain metastasis or brain metastasis progression from the brain surgery

    Months

Study Arms (1)

WGS/TME evaluation

EXPERIMENTAL

This is not intervention clinical trial design. We explore whole genome sequencing and tumor microenvironment evaluation for brain metastasis specimen in breast cancer patients.

Procedure: WGS/TME evaluation

Interventions

WGS/TME evaluationPROCEDURE

WGS/TME evaluation with blood and brain metastasis tissue during brain metastasis curative surgery

WGS/TME evaluation

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer
  • Brain metastasis curative surgery patient

You may not qualify if:

  • Gamma Knife surgery patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji-Yeon Kim

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Ji-Yeon Kim

CONTACT

82-2-3410-3459jyeon25@skku.edu

Mee Ryung Hong

CONTACT

82-2-2148-7147ring7629@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2024

First Posted

March 26, 2024

Study Start

April 6, 2023

Primary Completion

February 5, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)