Evaluating lymph node dissection for breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of ipsilateral supraclavicular lymph node dissection in patients with newly diagnosed locally advanced breast cancer. It aims to determine whether this surgical approach can improve prognosis compared to standard radiation therapy. The study is a prospective, multicenter, non-interference real-world analysis, focusing on various endpoints including recurrence-free survival and overall survival. The research will also assess the incidence of complications such as lymphedema and the quality of life of patients post-treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: xiuchun Chen
• Email: zlyychenxiuchun3921@zzu.edu.cn
• Phone: 0371-65587405

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.