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

ConditionsBreast CancerNode-negative Breast CancerEarly-Stage Invasive Breast Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Whole Breast Irradiation

    Radiation

    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.

  • Partial Breast Irradiation

    Radiation

    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).

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: Whole Breast Irradiation (WBI)Active comparator 1 intervention
Group B: Partial Breast Irradiation (PBI)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

5-Year Recurrence-Free Survival Rate

Proportion of patients free from a first RFS event at 5 years. An RFS event is defined as the first occurrence of ipsilateral invasive breast recurrence, ipsilateral regional nodal recurrence (including axillary), distant metastasis, or breast cancer death. Measured from date of randomization to first event.

Time frame
5 years from randomization

Secondary outcomes

1

5-Year Axillary Recurrence Rate

Incidence of axillary nodal recurrence.

Time frame
5 years from randomization
2

5-year locoregional recurrence rate

Incidence of ipsilateral breast or ipsilateral regional (axillary, supraclavicular or IMN) recurrence.

Time frame
5 years from randomization
3

5-Year Overall Survival

survival from randomization to death from any cause

Time frame
5 years from randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

National Institute of Health, Korea

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: