Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

Study Overview
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Brief Summary
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The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

Detailed Description
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A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.

Official Title
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Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: hypofractionated partial breast irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age≥ 50 years Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection Negative surgical margins Pathologically confirmed invasive breast cancer A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2- Tumor bed is labeled with Titanium clips Received adjuvant hormonal treatment No adjuvant chemotherapy ECOG:0-1 Written informed consent. Exclusion Criteria: Age<50 years KPS<70 Treated with neoadjuvant chemotherapy Treated or being treated with chemotherapy 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: 50 Years
Maximum Age: 85 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-PBI<br>Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks. | Radiation: hypofractionated partial breast irradiation<br>* deliver 40Gy/15Fx to tumor bed areas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of breast cosmetic outcome | The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system | Baseline, and three years after the completion of radiation therapy | 

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 | 3weeks, 5weeks,1 and 3 months after treatment beginning | 
| Late complications | Complications related to radiation treatment after more than 3 months. | 3 years | 
| Ipsilateral breast tumor recurrence rate | The pathological confirmed tumor recurrence in the same breast | 5 years | 
| Local-regional recurrence | Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain. | 5 years | 
| Disease free survival | The interval from diagnosis to disease recurrence or death or last visit. | 5 years | 
| Overall survival | The interval from diagnosis to death or last visit | 5 years | 

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