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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subclavian lymph node dissection+radiotherapy group | Subclavian lymph node dissection+radiotherapy |
| |
| Simple clavicular region radiotherapy group | Simple clavicular region radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subclavian lymph node dissection+radiotherapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraclavicular recurrence free survival in group A patients | The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up. | 5th year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival | The time from surgery to the occurrence of recurrence, metastasis, or last follow-up. | 5th year after surgery |
| Intraclavicular recurrence free survival in group B patients |
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Inclusion Criteria:
Exclusion Criteria:
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cT1-4N3M0 breast cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiuchun Chen | Contact | 0371-65587405 | zlyychenxiuchun3921@zzu.edu.cn | |
| Minhao Lv | Contact | 0371-65587405 | zlyylvminhao2789@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| xiuchun Chen | Henan Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Simple clavicular region radiotherapy | Procedure | If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy. |
|
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The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up
| 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 | 5th year after surgery |
| Overall survival of patients in Group A/B | The time from surgery to patient death or last follow-up | 5th year after surgery |
| Number of adverse events | Complications related to surgery and radiotherapy | 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. | 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. | 2th year after surgery |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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