NCT06605521

To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients

To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients: A Prospective, Multicenter, Non-interventionist Real World Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Subclavian lymph node dissection+radiotherapy	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.
PROCEDURE	Simple clavicular region radiotherapy	If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.

Timeline

• Start date: 2023-04-04
• Primary completion: 2027-04-04
• Completion: 2027-04-04
• First posted: 2024-09-20
• Last updated: 2024-09-20

Locations

1 site across 1 country: China