Breast CancerNCT03568981
Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer
An observational study of Breast Cancer, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Partial breast irradiation and Whole breast irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2018to 11 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing radiotherapy after breast-conservating surgery at an academic center
Who may be able to join
- 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)
Who cannot join
- Recurrent breast cancer
- History of ipsilateral breast irradiation
- Positive resection margin status after breast surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Korea, 120-752
YongBae Kim, MD, 82-10-6256-2592, ybkim3@yuhs.ac
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- Partial breast irradiation, Whole breast irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Partial Breast Irradiation (PBI) | Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer Receives: Radiation: Partial breast irradiation | |
| Whole Breast Irradiation (WBI) | Patients receiving whole breast irradiation for breast cancer Receives: Radiation: Whole breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of patient reported psychosocial functioning score
Patient reported psychosocial functioning measured in 7 point Likert scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 2 year after radiotherapy (allowed to plus 8 weeks)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 year after radiotherapy (allowed to plus 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start11 Apr 2018
- Primary completion11 Apr 2023 (estimated)
- Study completion11 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568981
- Sponsor's protocol ID
- 4-2018-0160
- Status last verified
- Jun 2018
- First submitted
- 15 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37201757
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer
- ClinicalTrials.gov ID
- NCT03568981
- Acronym / sponsor ID
- 4-2018-0160
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 11 Apr 2023 (estimated)
- Study completion
- 11 Apr 2023 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Breast Irradiation (PBI) | – | Radiation: Partial breast irradiationPatients receiving 5-fraction stereotactic partial breast irradiation for breast cancer |
| Whole Breast Irradiation (WBI) | – | Radiation: Whole breast irradiationPatients receiving whole breast irradiation for breast cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing radiotherapy after breast-conservating surgery at an academic center
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Recurrent breast cancer
- History of ipsilateral breast irradiation
- Positive resection margin status after breast surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial breast irradiationAfter 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. | Radiation | Partial Breast Irradiation (PBI) |
| Whole breast irradiationAfter 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. | Radiation | Whole Breast Irradiation (WBI) |
Primary outcome
Change of patient reported psychosocial functioning score
Time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
Patient reported psychosocial functioning measured in 7 point Likert scale
Change of patient reported psychosocial functioning score
Time frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported psychosocial functioning measured in 7 point Likert scale
Change of patient reported patient treatment satisfaction score
Time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
Patient reported patient treatment satisfaction measured in 7 point Likert scale
Change of patient reported patient treatment satisfaction score
Time frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported patient treatment satisfaction measured in 7 point Likert scale
Change of patient reported physical functioning score
Time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
Patient reported physical functioning measured in 7 point Likert scale
Change of patient reported physical functioning score
Time frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported physical functioning measured in 7 point Likert scale
Change of patient reported body image score
Time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
Patient reported body image score measured in 7 point Likert scale
Change of patient reported body image score
Time frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported body image score measured in 7 point Likert scale
Change of breast cosmesis measures (excellent/good/poor)
Time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy
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.
Change of breast cosmesis measures (excellent/good/poor)
Time frame: 2 year after radiotherapy (allowed to plus 8 weeks)
breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software
Change of breast-tissue fibrosis measures (gram)
Time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy
breast-tissue fibrosis is measured by tissue compliance meter device.
Change of breast-tissue fibrosis measures (gram)
Time frame: 2 year after radiotherapy (allowed to plus 8 weeks)
breast-tissue fibrosis is measured by tissue compliance meter device.
2 secondary outcomes
Incidence of Radiotherapy-related complications
Time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy)
Incidence of Radiotherapy-related complications
Time frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 37201757Byun 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Bae Kim, MD, PhD (82-2228-8095, ybkim3@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of patient reported psychosocial functioning score (time frame: Before radiotherapy (allowed to 8 weeks before radiotherapy)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.