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Clinical Trials/NCT06583655
NCT06583655
Active, not recruiting
Not Applicable

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

Ruijin Hospital1 site in 1 country205 target enrollmentOctober 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Invasive
Sponsor
Ruijin Hospital
Enrollment
205
Locations
1
Primary Endpoint
Percentage of patients with arm lymphedema
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
June 30, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

QIWEIXIANG

Deputy Chief Physician

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed invasive breast cancer;
  • Age between 18 and 80 years;
  • 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;
  • 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;
  • 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

Outcomes

Primary Outcomes

Percentage of patients with arm lymphedema

Time Frame: 2 year

Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

Secondary Outcomes

  • Disease free survival(5 years)
  • Overall survival(5-year)

Study Sites (1)

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