Partial Breast Irradiation Without Sentinel Lymph Node Biopsy in Low-Risk Early Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age40+
SponsorSamsung Medical Center
About this trial
This is a multicenter, randomized, phase III non-inferiority trial in women aged 40 years or older with clinically node-negative (cN0), pathologically pT1 (≤2 cm), grade 1-2, lymphovascular invasion (LVI)-negative invasive breast cancer treated with breast-conserving surgery (BCS) in whom sentinel lymph node biopsy (SLNB) was omitted (pNx). Eligible patients are randomized 1:1 to partial breast irradiation (PBI) or whole breast irradiation (WBI). The primary aim is to determine whether PBI is non-inferior to WBI with respect to the 5-year recurrence-free survival (RFS) rate. Secondary aims include comparison of axillary recurrence, overall survival, locoregional recurrence, treatment-related toxicity, and quality of life between arms.
Eligibility criteria
Qualifiers
Female ≥40 years with histologically confirmed unilateral invasive breast cancer.
No suspicious nodal metastasis on preoperative axillary ultrasound (cN0).
Single lesion in the affected breast on preoperative breast ultrasound and mammography.
Treated with breast-conserving surgery with pathologically negative margins for the invasive tumor.
Disqualifiers
History of malignancy other than breast cancer within 5 years (except adequately treated non-melanoma skin cancer, or carcinoma in situ excluding breast carcinoma in situ).
Preoperative diagnosis of carcinoma in situ without axillary nodal sampling, subsequently diagnosed as invasive breast cancer on final pathology with SLNB omitted.
Lymphovascular invasion present (LVI+).
Multifocal or multicentric tumor in the same breast confirmed radiologically or pathologically.
Trial design
Treatments tested in this trial
- Whole Breast Irradiation
- Partial Breast Irradiation
Treatment groups
520 Participants
are divided into 2 treatment groupsSponsors and collaborators
Samsung Medical Center
Lead sponsor
National Institute of Health, Korea
Collaborator
Source ClinicalTrials.gov