Not Yet RecruitingNot Applicable

Supraclavicular Lymph Node Dissection for Ipsilateral Supraclavicular Lymph Node Metastatic Breast Cancer

452 participantsStarted 2024-05-01

Plain-language summary

The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.

Who can participate

Age range35 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Previously untreated primary breast cancer with supraclavicular lymph node metastasis or supraclavicular lymph node metastasis without other metastasis within 5 years after combined therapy; The diagnostic criteria refer to the diagnostic criteria for "primary breast cancer" and "Stage pN3c" in the AJCC Guidelines published on November 8, 2018;
✓. Supraclavicular lymph node metastasis was confirmed by pathology;
✓. Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
✓. Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
✓. Have at least one measurable target lesion according to RECIST criteria;
✓. ECOG score ≦ 1;
✓. The level of organ function must meet the following requirements: adequate bone marrow reserve: absolute counts of neutrophils (lobed and band neutrophils) ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. Liver: Bilirubin \<1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3.0 times the upper limit of normal. Renal: Creatinine clearance ≥ 45 mL/min;
✓. No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;

Exclusion criteria

✕. The range of metastasis exceeds the neck IV and VB region;
✕. En-bloc resection cannot be achieved;
✕. Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy;
✕. Preoperative examination found distant metastasis;
✕. Pregnant, lactating or inflammatory breast cancer patients;
✕. Diseases associated with immune, endocrine or cardiovascular systems;
✕. Previous history of other tumors or combined with other tumors;
✕. Refusing to comply with the study protocol and refusing to sign the informed consent

What they're measuring

DFS

Timeframe: 5-year

Trial details

NCT IDNCT06383663

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Weidong Wei, Professor

+8613822278328 weiwd@sysucc.org.cn

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