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Partial Breast Irradiation Without Sentinel Lymph Node Biopsy in Low-Risk Early Breast Cancer

NCT07757958 ยท Status: NOT_YET_RECRUITING ยท Phase: PHASE3 ยท Type: INTERVENTIONAL ยท Enrollment: 520

Last updated 2026-08-11

No results posted yet for this study

Summary

This is a multicenter, randomized, phase III non-inferiority trial in women aged 40 years or older with clinically node-negative (cN0), pathologically pT1 (โ‰ค2 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.

Conditions

  • Breast Cancer
  • Node-negative Breast Cancer
  • Early-Stage Invasive Breast Carcinoma

Interventions

RADIATION

Whole Breast Irradiation

Total dose 26-45 Gy in 5-20 fractions; each institution applies a pre-selected fractionation schedule consistently. CTV defined per ESTRO guideline to include the whole breast parenchyma; PTV with institutional set-up margin (e.g., 5-7 mm). Tumor bed boost (sequential 10-16 Gy in 4-8 fractions, or simultaneous integrated boost \[SIB\]) per institutional standard. Regional nodal irradiation and high-tangent technique not permitted; axillary levels I-III contoured for dosimetric analysis only.

RADIATION

Partial Breast Irradiation

Total dose 30-40 Gy in 5-15 fractions. Recommended schedules: 30 Gy in 5 fractions (once daily \[QD\] or twice daily \[BID\]); or 40.05 Gy in 15 fractions (QD over \~3 weeks). Axillary levels I-III contoured for incidental dosimetric analysis only (not a treatment target).

Sponsors & Collaborators

  • National Institute of Health, Korea

    collaborator OTHER_GOV

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2036-06-30
Completion
2036-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757958 on ClinicalTrials.gov