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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Partial breast irradiation
* Radiation: Whole breast irradiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Partial Breast Irradiation (PBI)<br>Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer | Radiation: Partial breast irradiation<br>* 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.<br>|
| Whole Breast Irradiation (WBI)<br>Patients receiving whole breast irradiation for breast cancer | Radiation: Whole breast irradiation<br>* 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.<br>|

What is the study measuring?
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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) |