Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Invasive
• Interventions: Radiation: SLND(clinical low risk); Radiation: SLND(clinical high risk, genomic low risk); Radiation: SLND alone ,clinical high risk and genomic high risk group; Radiation: Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)

• Registration Number: NCT06583655
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-08
• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-01
• Study First Posted: 2024-09-04
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 205

Inclusion Criteria

• 1. Histologically confirmed invasive breast cancer; 2. Age between 18 and 80 years; 3. cN0 breast cancer underwent radical surgery combined with Sentinel Lymph Node Dissection (SLND)alone with SLND positive or SLND and axillary lymph node dissection (ALND) with positive lymph node metastasis; 4. for cN0 breast cancer treated with Sentinel Lymph Node Dissection (SLND)alone cohorts, the regional lymph node irradiation area was determined according to the clinical risk model(tumor size， percent of positive sentinel lymph node, LVI status and metastatic size of Sentinel Lymph Node) and genomic risk model assessment, which could be classified into three cohorts: clinical low risk, clinical high risk but genomic low risk, clinical and genomic high risk; 5. Ability to understand and willingness to participate the research and sign the consent form

Exclusion Criteria

• • Pathologically positive ipsilateral supraclavicular lymph node

  • Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes;
  • Pregnant or lactating women;
  • Severe non-neoplastic medical comorbidities;
  • History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix;
  • simultaneous contralateral breast cancer;
  • Definitive pathological or radiologic evidence of distant metastatic disease;
  • Previous radiotherapy to the neck, chest and/or ipsilateral axillary region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sentinel Lymph Node Dissection alone , clinical low risk group	SLND(clinical low risk)	patients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.
Sentinel Lymph Node Dissection alone , clinical high risk but genomic low risk group	SLND(clinical high risk, genomic low risk)	patients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.
Sentinel Lymph Node Dissection alone ,clinical high risk and genomic high risk group	SLND alone ,clinical high risk and genomic high risk group	patients treated with surgery and Sentinel Lymph Node Dissection alone with positive lymph node metastasis.
with Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)	Sentinel Lymph Node Dissection(SLND) + axillary lymph node dissection(ALND)	patients treated with surgery and Sentinel Lymph Node Dissection and ALND with positive lymph node metastasis.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with arm lymphedema	2 year	Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

Secondary Outcome Measures

Name	Time	Method
Disease free survival	5 years	Number of patients with an oncological event (local, regional and distant recurrence free survival)
Overall survival	5-year	Number of patient alive after 5 years of follow up

Trial Locations

Locations (1)

Ruijin hospital, Shanghai jiaotong university school of medicine; 🇨🇳 Shanghai, China