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NOT YET RECRUITING
NCT07757958
PHASE3

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

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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 (≤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.

Official title: A Phase III Randomized Trial of Partial Versus Whole Breast Radiotherapy in Clinically Node-Negative Early Breast Cancer Omitting Sentinel Lymph Node Biopsy (APROOB Trial)

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

520

Start Date

2026-08-01

Completion Date

2036-06

Last Updated

2026-08-11

Healthy Volunteers

No

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).

Locations (1)

Samsung Medical Center

Seoul, South Korea