Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)

Recruiting

• Conditions: Radiation Therapy Complication; Breast Cancer; Metastatic Breast Cancer

• Registration Number: NCT05907681
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-11
• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Primary Completion: 2028-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• 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

Exclusion Criteria

• unable to adhere to the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local control rate	1-year	LC after radiation therapy

Secondary Outcome Measures

Name	Time	Method
Treatment-related toxicities	1-year	Acute and chronic radiation toxicities according to CTCAE v5.0
Disease-free survival	1-year	disease-free survival rate after the time of RT
Overall survival rate	1-year

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of