A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 537
- Locations
- 1
- Primary Endpoint
- locoregional control rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 (Radiation)
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)
Investigators
Shulian Wang,MD
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences