RecruitingNCT06605521

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


Sponsor

Henan Cancer Hospital

Enrollment

300 participants

Start Date

Apr 4, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether surgically removing lymph nodes above the collarbone (supraclavicular nodes) improves outcomes for breast cancer patients whose cancer has spread to those nodes. It compares surgery plus radiation to radiation alone. **You may be eligible if...** - You are a female patient aged 80 or younger - You have been diagnosed with invasive breast cancer confirmed by tissue biopsy - The cancer has spread to lymph nodes above your collarbone on the same side (confirmed by cytology or pathology) - You have known hormone receptor (ER, PR, HER2, Ki67) status - Your expected survival is more than 3 months - You have no major reasons why you cannot have surgery or radiation **You may NOT be eligible if...** - You have significant health contraindications to surgery or radiotherapy - Your survival is estimated at less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESubclavian 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.

PROCEDURESimple clavicular region radiotherapy

If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.


Locations(1)

Henan Cancer Hospital

Zhengzhou, Henan, China

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NCT06605521


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