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

Not Yet RecruitingPhase 3

Sponsor: Samsung Medical Center

Conditions: Breast Cancer, Node-negative Breast Cancer, Early-Stage Invasive Breast Carcinoma

Interventions: Whole Breast Irradiation, Partial Breast Irradiation

Countries: South Korea

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 overview

Sex: FEMALE

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.
* Sentinel lymph node biopsy not performed at surgery (pNx).
* Maximum diameter of invasive tumor ≤2 cm on final pathology (pT1).
* Histologic grade 1 or 2.
* Signed informed consent prior to enrollment.

Exclusion Criteria:

* 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.
* Bilateral or inflammatory breast cancer.
* Prior radiotherapy to the breast or thorax.
* Confirmed pathogenic or likely pathogenic variant in a hereditary breast cancer gene (including BRCA1/2).
* Recurrent breast cancer.

Locations (1)

Seoul, South Korea