Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

Study Overview
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Brief Summary
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This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.

Detailed Description
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This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.

Official Title
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A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer

Conditions
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Breast Neoplasms, Neoplasm Recurrence, Local

Intervention / Treatment
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* Radiation: Accelerated Partial Breast Irradiation


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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated Partial Breast Irradiation<br>Accelerated partial breast irradiation (APBI) to the region of tumour bed | Radiation: Accelerated Partial Breast Irradiation<br>* Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| locoregional control rate | ipsilateral breast and axilla nodal relapse rate | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | any death | 5 years | 
| disease-free survival | any recurrence or death | 5 years | 
| distant-metastasis survival | distant metastasis | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast conserving surgery, Accelerate partial breast irradiation, intensity-modulated radiation therapy, phase II