This study is designed to evaluate the feasibility and safety of axillary radiotherapy for early stage breast cancer with limited positive sentinel lymph nodes.
Randomized clinical trials have demonstrated that complete axillary lymph node dissection is not necessary in patients with 1-2 positive sentinel lymph nodes who undergo breast conserving surgery, whole breast irradiation, and systemic therapy. However, whether or not the regional lymph node should be irradiated and if radiation given, whether or not all levels of axillary lymph node and internal mammary and supraclavicular lymph node should be irradiated is unknown. The purpose of this study is to evaluate the feasibility and safety of axillary level I-II areas radiotherapy for early stage breast cancer with 1-2 positive sentinel lymph nodes and no further axillary lymph node dissection.
Study Type
OBSERVATIONAL
Enrollment
475
Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGAxillary recurrence
Time frame: 5 years
Local-regional recurrence
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Complications
Time frame: baseline,1,2,3,4,5 years
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