Overview
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.
Description
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.
Eligibility
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.