Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer
NCT ID: NCT05893966
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2022-11-29
2032-11-29
Brief Summary
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The main questions it aims to answer are:
* 7-year ipsilateral breast tumor recurrence
* 7-year disease-free survival
* 7-year locoregional recurrence
* 7-year overall survival
* Adverse events of radiation therapy
Participants will be assessed by multi-dimensional methods after radiation therapy:
* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
* Assessment for the adverse events according to CTCAE version 5.0
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Whole breast irradiation +/- tumor bed boost
Postoperative whole breast irradiation (3D-conformal radiation therapy or IMRT) with or without tumor bed boost (sequential or simultaneous integrated boost)
Eligibility Criteria
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Inclusion Criteria
* Pathological confirmation of HER2+ invasive breast cancer
* Eastern Cooperative Oncology Group performance status 0-2
* Informed consent of the participant
Exclusion Criteria
* Previous history of radiation therapy to ipsilateral breast
19 Years
FEMALE
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Haeyoung Kim
Associate professor
Principal Investigators
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Haeyoung Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-11-018
Identifier Type: -
Identifier Source: org_study_id
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