Status and phase
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About
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.
Full description
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:
The experimental group:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients aged 19 years or older.
A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
Patient with stage pN1 after surgery on histopathologic examination.
Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2.
Patients who agreed to participate in the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,106 participants in 2 patient groups
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Central trial contact
Bum-Sup Jang, MD. PhD.; Kyung Hwan Shin, MD. PhD.
Data sourced from clinicaltrials.gov
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