Breast Neoplasms, Neoplasm Recurrence, Local
Conditions
Brief summary
This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.
Detailed description
This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.
Interventions
RADIATIONAPBI
Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.
RADIATIONWBI
Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 |
|---|---|---|
| Number o participants with Grade 2 or more toxicity | 5 years | The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria: acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| locoregional recurrence | 5 years | ipsilateral breast and axillary nodal recurrence |
| overall survival | 5 years | any death |
| disease-free survival | 5 years | any recurrence or death |
| distant-metastasis survival | 5 years | distant metastasis |
| Quality of life measured with BR-23 questionnaire | 2 years | BR-23 questionnaire |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORShulian Wang, M.D.
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed