NCT05775757

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jan 2021Dec 2030

Study Start

First participant enrolled

January 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

February 15, 2023

Last Update Submit

June 27, 2025

Conditions

Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (24)

  • Change of cosmesis from baseline

    Evaluated by two blinded independent physicians based on photographs

    After 2-3 weeks after the start of radiation therapy (During radiation therapy)

  • Change of cosmesis from baseline

    Evaluated by two blinded independent physicians based on photographs

    2-3 weeks after the completion of radiation therapy

  • Change of cosmesis from baseline

    Evaluated by two blinded independent physicians based on photographs

    6 months after radiation therapy

  • Change of cosmesis from baseline

    Evaluated by two blinded independent physicians based on photographs

    1 year after radiation therapy

  • Change of cosmesis from baseline

    Evaluated by two blinded independent physicians based on photographs

    2 year after radiation therapy

  • Change of cosmesis from baseline

    Evaluated by two blinded independent physicians based on photographs

    5 year after radiation therapy

  • Change of fibrosis from baseline

    Evaluated using fibrometer measuring both breast

    After 2-3 weeks after the start of radiation therapy (During radiation therapy)

  • Change of fibrosis from baseline

    Evaluated using fibrometer measuring both breast

    2-3 weeks after the completion of radiation therapy

  • Change of fibrosis from baseline

    Evaluated using fibrometer measuring both breast

    6 months after radiation therapy

  • Change of fibrosis from baseline

    Evaluated using fibrometer measuring both breast

    1 year after radiation therapy

  • Change of fibrosis from baseline

    Evaluated using fibrometer measuring both breast

    2 year after radiation therapy

  • Change of fibrosis from baseline

    Evaluated using fibrometer measuring both breast

    5 year after radiation therapy

  • Change of patient-reported outcome from baseline

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

    After 2-3 weeks after the start of radiation therapy (During radiation therapy)

  • Change of patient-reported outcome from baseline

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

    2-3 weeks after the completion of radiation therapy

  • Change of patient-reported outcome from baseline

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

    6 months after radiation therapy

  • Change of patient-reported outcome from baseline

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

    1 year after radiation therapy

  • Change of patient-reported outcome from baseline

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

    2 year after radiation therapy

  • Change of patient-reported outcome from baseline

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

    5 year after radiation therapy

  • Physician assessed toxicity

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

    After 2-3 weeks after the start of radiation therapy

  • Physician assessed toxicity

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

    2-3 weeks after the completion of radiation therapy

  • Physician assessed toxicity

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

    6 months after radiation therapy

  • Physician assessed toxicity

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

    1 year after radiation therapy

  • Physician assessed toxicity

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

    2 year after radiation therapy

  • Physician assessed toxicity

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

    5 year after radiation therapy

Interventions

Hypofractionated radiation therapyRADIATION

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any breast cancer patients treated with curative surgery is eligible except for history of thoracic radiation therapy.

You may qualify if:

  • Breast cancer treated with curative surgery

You may not qualify if:

  • History of thoracic radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Haeyoung Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haeyoung Kim, MD, PhD

CONTACT

82-2-3410-2612haeyoung0131.kim@samsung.com

Nalee Kim, MD, PhD

CONTACT

82-2-3410-2612rodr.naleekim@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 20, 2023

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)