About this trial
For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Although guidelines such as NCCN recommend simple clavicular radiation therapy, there are studies suggesting that supraclavicular lymph node dissection can improve prognosis, and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection. Therefore, ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer. The effectiveness and safety of (stage IIIc) treatment still require prospective research to confirm.This project is a prospective, multicenter, non-interference real world study. In the real world study, the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged ≤ 80 years old.
ECOG score 0-1 points;
Breast cancer meets the following criteria: histologically diagnosed as invasive breast cancer, known ER, PR, HER2, KI67 status, pathologically diagnosed as ipsilateral supraclavicular lymph node metastasis (both cytology and histopathology);
Estimated patient survival time exceeding three months;
Disqualifiers
Stage IV (metastatic) breast cancer;
Bilateral breast cancer;
Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment;
History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
Trial population
cT1-4N3M0 breast cancer
Trial design
Case-control
Prospective
Treatments tested in this trial
Subclavian lymph node dissection+radiotherapy
Procedure/SurgeryThe patient grouping is determined jointly by the researchers and participants, and patients in Group A are selected for supraclavicular lymph node dissection and radiotherapy.
Simple clavicular region radiotherapy
Procedure/SurgeryIf the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.
Treatment groups
Trial outcomes
Primary outcomes
Intraclavicular recurrence free survival in group A patients
The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up.
Secondary outcomes
Disease-Free Survival
The time from surgery to the occurrence of recurrence, metastasis, or last follow-up.
Intraclavicular recurrence free survival in group B patients
The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up
Regional lymph node recurrence free survival in group A/B patients
The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up
Overall survival of patients in Group A/B
The time from surgery to patient death or last follow-up
Sponsors and contacts
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