This prospective study is designed to evaluate the feasibility, efficacy, and safety of risk-stratified hypofractionated radiotherapy after breast-conserving surgery in patients with early breast cancer.
Eligible patients with early breast cancer who have undergone breast-conserving surgery will be stratified into a high-risk group or a low-risk group according to the presence or absence of predefined high-risk factors. Patients in the high-risk group will receive whole-breast irradiation with a simultaneous integrated boost to the tumor bed. The prescribed dose will be 36 Gy in 15 fractions over 3 weeks to the whole breast and 48 Gy in 15 fractions over 3 weeks to the tumor bed. Patients in the low-risk group will receive partial-breast irradiation. Two hypofractionated schedules may be used: 40.05 Gy in 15 fractions over 3 weeks or 26 Gy in 5 fractions over 1 week. Patients will be followed during and after radiotherapy to evaluate treatment efficacy, recurrence rates, and acute and late radiation-related toxicities.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
649
Whole-breast irradiation: 36 Gy in 15 fractions; Tumor bed boost: 48 Gy in 15 fractions
Partial-breast irradiation: 40.05 Gy in 15 fractions or 26 Gy in 5 fractions
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Local recurrence rate
Ipsilateral breast recurrence rate
Time frame: Five years
Disease-free survival rate
Disease-free survival rate
Time frame: Five years
Radiation-related adverse events
Adverse events
Time frame: Five years
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