NCT06583655

Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer

A Prospective Study of Individualized Regional Node Irradiation for Sentinel Node-positive Breast Cancer Without Axillary Dissection Based on Clinical and Genomic Risk Assessment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. Since the publication of IBCSG23-01, ACOSOG Z0011 and AMAROS study, these studies indicated that there was no significant difference in recurrence and overall survival rates between the ALNB and SLNB+ALND followed by adjuvant radiotherapy. Therefore, an adaptation of the strategy to omit axillary lymph node dissection in patients with low-risk axillary involvement who are treated with curative surgery and systematic therapy. However, they also pose new challenges for adjuvant radiotherapy decisions. In the Z0011 study, patients were required to receive breast tangent field radiotherapy. In the AMAROS study, axillary radiotherapy included level I-III axillary lymph node drainage areas and the supraclavicular area, but the study results showed a local recurrence rate of only 1.19% at 5 years in the axillary radiotherapy group. Consequently, there is considerable controversy among clinical experts about whether a combined regional lymphatic drainage area radiotherapy strategy is necessary for low-burden sentinel lymph node metastasis breast cancer patients. In contrast, results from the EORTC-22922 and MA-20 studies, which included patients undergoing axillary lymph node dissection, showed that adjuvant radiotherapy to the entire lymphatic drainage area, including the internal mammary region, reduced the risk of disease-free survival and breast cancer-specific mortality. Therefore, the adjuvant radiotherapy strategy for early breast cancer patients with low-burden sentinel lymph node metastasis remains controversial, with a lack of high-level evidence to support it.

Conditions

• Breast Cancer Invasive

Interventions

Type	Name	Description
RADIATION	SLND(clinical low risk)	treated with whole breast irradiation(WBI)alone 50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx or no PMRT
RADIATION	SLND(clinical high risk, genomic low risk)	treated with whole breast irradiation(WBI)/Post-Mastectomy Adjuvant Radiotherapy(PMRT) + regional node irradiation (Axillary +supraclavicular radiotherapy),the radiation dose could be conventional radiation or hypo-fraction irradiation:50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx
RADIATION	SLND alone ,clinical high risk and genomic high risk group	treated with whole breast irradiation(WBI)/Post-Mastectomy Adjuvant Radiotherapy(PMRT) + regional node irradiation (Internal Mammary Node Irradiation+ axillary +supraclavicular radiotherapy),the radiation dose could be conventional radiation or hypo-fraction irradiation:50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx
RADIATION	Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)	treated with whole breast irradiation(WBI)/Post-Mastectomy Adjuvant Radiotherapy(PMRT) + regional node irradiation (Internal Mammary Node +supraclavicular radiotherapy),the radiation dose could be conventional radiation or hypo-fraction irradiation:50Gy/25Fx + 10Gy/5Fx or 40Gy/15Fx + 10Gy/4Fx

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2024-09-04
• Last updated: 2025-07-31

Locations

1 site across 1 country: China