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

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05907681
Collaborator
(none)
400
Enrollment
1
Location
127.7
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)
    Actual Study Start Date :
    May 11, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2028
    Anticipated Study Completion Date :
    Dec 31, 2033

    Outcome Measures

    Primary Outcome Measures

    1. Local control rate [1-year]

      LC after radiation therapy

    Secondary Outcome Measures

    1. Overall survival rate [1-year]

    2. Disease-free survival [1-year]

      disease-free survival rate after the time of RT

    3. Treatment-related toxicities [1-year]

      Acute and chronic radiation toxicities according to CTCAE v5.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 100 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Haeyoung Kim, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haeyoung Kim, Associate professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT05907681
    Other Study ID Numbers:
    • 2023-04-032-003
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    Jun 1, 2023
    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 Jun 18, 2023