Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery

Study Overview
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Brief Summary
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The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.

Official Title
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Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18-60 years old Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection Pathologically confirmed invasive breast cancer A pathological T1-2N0M0 tumor Tumor bed is labeled with Titanium clips Negative surgical margins Written informed consent. Exclusion Criteria: KPS<70 Treated with neoadjuvant chemotherapy Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm) With severe comorbidity Previous breast cancer or other malignant tumor history Previous radiotherapy for breast or thorax Medical contraindication for radiotherapy Pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HF-WBI<br>Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy. | Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost<br>* deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0 | acute toxicity related to irradiation such as lung and skin | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute radiation-induced toxicity assessed by CTCAE v4.0 | acute toxicity related to skin and lung | during radiotherapy; 3months; 6 months | 
| local-regional recurrence |  | 5 years | 
| Disease free survival |  | 5 years | 
| Overall survival Over survival |  | 5 years | 
| Late complications |  | 1,2,3,4,5years | 
| cosmetic effect measured by Harvard 4 scale evaluation system |  | 2,3,4,5years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, hypofractionated whole breast irradiation