A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Accelerated Partial Breast Irradiation
- Conditions
- Breast Neoplasms
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 537
- Locations
- 1
- Primary Endpoint
- locoregional control rate
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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
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.
Investigators
Shulian Wang
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Eligibility Criteria
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.
Arms & Interventions
Accelerated Partial Breast Irradiation
Accelerated partial breast irradiation (APBI) to the region of tumour bed
Intervention: Accelerated Partial Breast Irradiation
Outcomes
Primary Outcomes
locoregional control rate
Time Frame: 5 years
ipsilateral breast and axilla nodal relapse rate
Secondary Outcomes
- distant-metastasis survival(5 years)
- overall survival(5 years)
- disease-free survival(5 years)