NCT03568981

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

April 11, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2023

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

5 years

First QC Date

May 15, 2018

Last Update Submit

June 13, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (2)

  • Incidence of Radiotherapy-related complications

    Before radiotherapy (allowed to 8 weeks before radiotherapy)

  • Incidence of Radiotherapy-related complications

    2 year after radiotherapy (allowed to plus 8 weeks)

Study Arms (2)

Partial Breast Irradiation (PBI)

Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer

Radiation: Partial breast irradiation

Whole Breast Irradiation (WBI)

Patients receiving whole breast irradiation for breast cancer

Radiation: Whole breast irradiation

Interventions

Partial breast irradiationRADIATION

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.

Partial Breast Irradiation (PBI)
Whole breast irradiationRADIATION

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)

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing radiotherapy after breast-conservating surgery at an academic center
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Korea, 120-752, South Korea

RECRUITING

Related Publications (1)

  • Byun HK, Chang JS, Kim H, Kim J, Han MC, Kim SY, Park RH, Kim CJ, Kim YB. Cosmetic Outcome and Toxicity After Stereotactic Accelerated Partial Breast Irradiation in Early Breast Cancer: A Prospective Observational Cohort Study. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):690-700. doi: 10.1016/j.ijrobp.2023.05.018. Epub 2023 May 17.

    PMID: 37201757DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yong Bae Kim, MD, PhD

CONTACT

82-2228-8095ybkim3@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 26, 2018

Study Start

April 11, 2018

Primary Completion

April 11, 2023

Study Completion

April 11, 2023

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)