NCT05907681

Brief Summary

This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started May 2023

Longer than P75 for all trials

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 Progress28%
May 2023Dec 2033

Study Start

First participant enrolled

May 11, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5.6 years

First QC Date

June 8, 2023

Last Update Submit

June 27, 2025

Conditions

Breast CancerMetastatic Breast CancerRadiation Therapy Complication

Outcome Measures

Primary Outcomes (1)

  • Local control rate

    LC after radiation therapy

    1-year

Secondary Outcomes (3)

  • Overall survival rate

    1-year

  • Disease-free survival

    1-year

  • Treatment-related toxicities

    1-year

Eligibility Criteria

Age19 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women treated with hypofractionated RT using IMRT, SBRT, or proton therapy for metastatic breast cancer

You may qualify if:

  • histologically confirmed breast cancer
  • presence of distant metastasis
  • radiation therapy using IMRT, SBRT, or proton therapy is done or planned
  • Able and willing to comply with the study protocol

You may not qualify if:

  • unable to adhere to the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Haeyoung Kim

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haeyoung Kim

CONTACT

+82-02-3410-2612haeyoung0131.kim@samsung.com

won kyung Cho

CONTACT

+821087328703wklove.cho@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

May 11, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2033

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

KR(1)