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SMC Radiation Oncology Breast Cancer Cohort Study

NCT05775757 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-06-29

No results posted yet for this study

Summary

The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.

The main question it aims to answer are:

* Changes in breast skin
* Factors related to breast skin changes
* Patient-reported outcomes
* Cosmetic outcomes

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

* Photographs
* Fibrometer
* Questionnaires (BREAST-Q)
* CTCAE version 4.03 evaluated by treating physicians

Conditions

  • Radiotherapy Side Effect

Interventions

RADIATION

Hypofractionated radiation therapy

Both 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Haeyoung Kim, MD, PhD · Samsung Medical Center

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-12-31
Completion
2030-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05775757 on ClinicalTrials.gov