Breast Neoplasms, Neoplasm Recurrence, Local
Conditions
Keywords
Breast conserving surgery, Accelerate partial breast irradiation, intensity-modulated radiation therapy, phase II
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.
Interventions
RADIATIONAccelerated Partial Breast Irradiation
Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| locoregional control rate | 5 years | ipsilateral breast and axilla nodal relapse rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | any death |
| disease-free survival | 5 years | any recurrence or death |
| distant-metastasis survival | 5 years | distant metastasis |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORShulian Wang, M.D.
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed