This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.
1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative breast cancer (TNBC) versus non-TNBC) The control group: * If patients received BCS, WBI+Regional RT * If patients received mastectomy, PMRT The experimental group: * If patients received breast conserving surgery, WBI alone * If patients received mastectomy, No PMRT
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,106
* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
Seoul National University Hospital
Seoul, Jongro-gu, South Korea
RECRUITINGDisease-Free Survival
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.
Time frame: 7-Year
Locoregional-Recurrence Free Survival
Time from randomization to recurrence of tumors in the ipsilateral chest wall, breast or regional lymph nodes (ipsilateral axillary/internal mammary/supraclavicular lymph nodes) or breast cancer-related death. \*\* Recurrence should be confirmed by histological diagnosis, but local recurrence can be diagnosed by clinical examination only when regional/remote or distant metastases already exist.
Time frame: 7-Year
Distant Metastases Free Survival
Time from randomization to the development of distant metastases or breast cancer-related death.
Time frame: 7-Year
Overall Survival
Time from randomization to the death due to any cause.
Time frame: 7-Year
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