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

Launched by HENAN CANCER HOSPITAL · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a specific surgery called ipsilateral supraclavicular lymph node dissection for women with locally advanced breast cancer. The goal is to find out if this surgery is effective and safe for patients whose breast cancer has spread to nearby lymph nodes located above the collarbone. While some guidelines recommend radiation therapy for this area, many hospitals still perform this type of surgery, and this study aims to gather more information on its benefits and risks.

To participate in the trial, women must be 80 years or younger, have a certain type of breast cancer that has been confirmed through tests, and have a good overall health score. Participants can expect to undergo the surgery and will be closely monitored for their health and recovery. The trial is currently recruiting participants, and it's important for those interested to be aware that they should not have advanced-stage breast cancer or other serious health conditions that would make surgery risky. This study will help doctors understand the best treatment options for women facing this challenging diagnosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female patients aged ≤ 80 years old.
• • 2. ECOG score 0-1 points;
• • 3. 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);
• • 4. Estimated patient survival time exceeding three months;
• • 5. No obvious contraindications for surgery or radiotherapy;
• • 6. The researcher judged that they were able to comply with the research protocol.
• • 7. Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers not to affect the research protocol can be enrolled normally.
• • 8. Voluntarily participate in this study and sign an informed consent form.
• Exclusion Criteria:
• • 1. Stage IV (metastatic) breast cancer;
• • 2. Bilateral breast cancer;
• • 3. Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment;
• • 4. History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
• • 5. Individuals with severe primary diseases such as cardiovascular, cerebrovascular, liver, and kidney that are difficult to tolerate surgery or radiation therapy;
• • 6. Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
• • 7. Suffering from severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study.