Evaluating lymph node dissection for breast cancer treatment
To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients: A Prospective, Multicenter, Non-interventionist Real World Study
This study is testing if a specific type of surgery for breast cancer can help patients live longer and have fewer complications compared to regular radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06605521 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 80 or younger with histologically confirmed invasive breast cancer and ipsilateral supraclavicular lymph node metastasis.
Not a fit: Patients with stage IV metastatic breast cancer or bilateral breast cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and quality of life for breast cancer patients with supraclavicular lymph node metastasis.
How similar studies have performed: While there is ongoing debate regarding the effectiveness of supraclavicular lymph node dissection, some studies suggest potential benefits, making this approach a subject of interest rather than a fully established treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhengzhou, Henan
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: xiuchun Chen
- Email: zlyychenxiuchun3921@zzu.edu.cn
- Phone: 0371-65587405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.