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.
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. The main endpoint of the study was recurrence free survival on the ipsilateral clavicle. The secondary study endpoint is disease-free survival; Ipsilateral supraclavicular relapse-free survival; Rregional lymph node relapse-free survival; Overall survival; Security; The incidence of upper limb lymphedema; Patient's quality of life.
Study Type
OBSERVATIONAL
Enrollment
300
The patient grouping is determined jointly by the researchers and participants, and patients in Group A are selected for supraclavicular lymph node dissection and radiotherapy.
If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGIntraclavicular recurrence free survival in group A patients
The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up.
Time frame: 5th year after surgery
Disease-Free Survival
The time from surgery to the occurrence of recurrence, metastasis, or last follow-up.
Time frame: 5th year after surgery
Intraclavicular recurrence free survival in group B patients
The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up
Time frame: 5th year after surgery
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
Time frame: 5th year after surgery
Overall survival of patients in Group A/B
The time from surgery to patient death or last follow-up
Time frame: 5th year after surgery
Number of adverse events
Complications related to surgery and radiotherapy
Time frame: through study completion, an average of 2 year
The incidence of upper limb lymphedema in group A/B patients at 2 years after surgery
Measure the circumference using the circumference method, with the styloid process of the ulna as the starting point, spaced 10cm apart and measured up to 40cm.
Time frame: 2th year after surgery
Patient's quality of life
Evaluate using the EORTC-QLQ-C30 V3 (European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3)scale.EORTC-QLQ-C30 V3 is the core scale of the quality of life measurement system developed by the European Organization for Research and Treatment of Cancer (EORTC) for cancer patients. The original scores of each item in the scale need to be converted into standardized scores ranging from 0 to 100 using linear formulas. The higher the scores of each functional dimension, the better the functional status; The higher the score of the symptom scale and individual items, the more obvious the symptoms and the poorer the quality of life.
Time frame: 2th year after surgery
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