Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer

NCT ID: NCT05893966

Last Updated: 2025-06-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2032-11-29

Brief Summary

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The purpose of this study is to analyze treatment outcomes related to tumor bed boost of postoperative radiation therapy in patient with HER2+ breast cancer who underwent breast conserving surgery.

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Female patients with age minimum 19
* Pathological confirmation of HER2+ invasive breast cancer
* Eastern Cooperative Oncology Group performance status 0-2
* Informed consent of the participant

Exclusion Criteria

* Pathological confirmation of ductal carcinoma in situ of the breast
* Previous history of radiation therapy to ipsilateral breast
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Haeyoung Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Haeyoung Kim, MD, PhD

Role: CONTACT

82-2-3410-2612

Facility Contacts

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Haeyoung Kim, MD, PhD

Role: primary

82-2-3410-2612

Other Identifiers

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2022-11-018

Identifier Type: -

Identifier Source: org_study_id

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