Status:
RECRUITING
To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Locally Advanced Breast Cancer
Eligibility:
FEMALE
18-80 years
Brief 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 guid...
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 guid...
Eligibility Criteria
Inclusion
- Female patients aged ≤ 80 years old.
- ECOG score 0-1 points;
- 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);
- Estimated patient survival time exceeding three months;
- No obvious contraindications for surgery or radiotherapy;
- The researcher judged that they were able to comply with the research protocol.
- 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.
- Voluntarily participate in this study and sign an informed consent form.
Exclusion
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment;
- History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
- Individuals with severe primary diseases such as cardiovascular, cerebrovascular, liver, and kidney that are difficult to tolerate surgery or radiation therapy;
- Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
- 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.
Key Trial Info
Start Date :
April 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 4 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06605521
Start Date
April 4 2023
End Date
April 4 2027
Last Update
September 20 2024
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000