Randomized Trial of Accelerated Partial Breast Irradiation

Study Overview
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Brief Summary
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This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

Detailed Description
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This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.

Official Title
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A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer

Conditions
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Breast Neoplasms, Neoplasm Recurrence, Local

Intervention / Treatment
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* Radiation: APBI
* Radiation: WBI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Life Expectation: > 5 years Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade Unifocal tumour (confirmed by diagnostic MRI) No lymphovascular invasion ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells) Negative radial resection margins of >= 2 mm Surgical clips placed in the tumor bed Written informed consent. Exclusion Criteria: Stage Ⅱ-Ⅲ Multifocal tumors Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), - - - invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive - - - lobular carcinoma Paget's disease of the nipple Underwent oncoplastic surgery of ipsilateral breast Underwent neoadjuvant chemotherapy or hormonal therapy Previous or simultaneous contralateral breast cancer Undergone ipsilateral chest wall radiotherapy Active collagen vascular disease.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APBI<br>Patients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks. | Radiation: APBI<br>* Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.<br>|
| Active Comparator: WBI<br>Patients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks. | Radiation: WBI<br>* Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number o participants with Grade 2 or more toxicity | The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria: acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locoregional recurrence | ipsilateral breast and axillary nodal recurrence | 5 years | 
| overall survival | any death | 5 years | 
| disease-free survival | any recurrence or death | 5 years | 
| distant-metastasis survival | distant metastasis | 5 years | 
| Quality of life measured with BR-23 questionnaire | BR-23 questionnaire | 2 years |