Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer

This study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Partial breast irradiation; Radiation: Whole breast irradiation

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yong Bae Kim, MD, PhD; Phone Number: 82-2228-8095; Email: ybkim3@yuhs.ac

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 120-752
      • Recruiting
      • Severance Hospital
      • Contact: YongBae Kim, MD; Phone Number: 82-10-6256-2592; Email: ybkim3@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing radiotherapy after breast-conservating surgery at an academic center

Description

Inclusion Criteria:

• Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS)
• Women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation
• Good performance status (ECOG 0-1)

Exclusion Criteria:

• Recurrent breast cancer
• History of ipsilateral breast irradiation
• Positive resection margin status after breast surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Partial Breast Irradiation (PBI); Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer	Radiation: Partial breast irradiation; After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.
Whole Breast Irradiation (WBI); Patients receiving whole breast irradiation for breast cancer	Radiation: Whole breast irradiation; After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of patient reported psychosocial functioning score	Patient reported psychosocial functioning measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Change of patient reported psychosocial functioning score	Patient reported psychosocial functioning measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Change of patient reported patient treatment satisfaction score	Patient reported patient treatment satisfaction measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Change of patient reported patient treatment satisfaction score	Patient reported patient treatment satisfaction measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Change of patient reported physical functioning score	Patient reported physical functioning measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Change of patient reported physical functioning score	Patient reported physical functioning measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Change of patient reported body image score	Patient reported body image score measured in 7 point Likert scale	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Change of patient reported body image score	Patient reported body image score measured in 7 point Likert scale	2 year after radiotherapy (allowed to plus 8 weeks)
Change of breast cosmesis measures (excellent/good/poor)	breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software - Investigators will whether there are any changes on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis after radiotherapy. Any differences of theses parameters according to the radiotherapy techniques (PBI vs. WBI) will be examed.	Before radiotherapy (allowed to 8 weeks before radiotherapy
Change of breast cosmesis measures (excellent/good/poor)	breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software	2 year after radiotherapy (allowed to plus 8 weeks)
Change of breast-tissue fibrosis measures (gram)	breast-tissue fibrosis is measured by tissue compliance meter device.	Before radiotherapy (allowed to 8 weeks before radiotherapy
Change of breast-tissue fibrosis measures (gram)	breast-tissue fibrosis is measured by tissue compliance meter device.	2 year after radiotherapy (allowed to plus 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Radiotherapy-related complications	Investigators will check whether there are any kinds of radiotherapy-related complications after PBI or WBI. Any differences of complications according to the radiotherapy techniques will be examed.	Before radiotherapy (allowed to 8 weeks before radiotherapy)
Incidence of Radiotherapy-related complications	Investigators will check whether there are any kinds of radiotherapy-related complications after PBI or WBI. Any differences of complications according to the radiotherapy techniques will be examed.	2 year after radiotherapy (allowed to plus 8 weeks)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Anticipated): April 11, 2023
• Study Completion (Anticipated): April 11, 2023

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 4-2018-0160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No