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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Breast Cancer
• Intervention / Treatment: Procedure: Subclavian lymph node dissection+radiotherapy; Procedure: Simple clavicular region radiotherapy

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 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.

The main endpoint of the study was recurrence free survival on the ipsilateral clavicle. The secondary study endpoint is disease-free survival; Ipsilateral supraclavicular relapse-free survival; Rregional lymph node relapse-free survival; Overall survival; Security; The incidence of upper limb lymphedema; Patient's quality of life.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: xiuchun Chen; Phone Number: 0371-65587405; Email: zlyychenxiuchun3921@zzu.edu.cn
• Study Contact Backup: Name: Minhao Lv; Phone Number: 0371-65587405; Email: zlyylvminhao2789@zzu.edu.cn

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Minhao Lv; Phone Number: 0371-65587405; Email: zlyylvminhao2789@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

cT1-4N3M0 breast cancer

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subclavian lymph node dissection+radiotherapy group; Subclavian lymph node dissection+radiotherapy	Procedure: Subclavian 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.; Other Names: experimental group
Simple clavicular region radiotherapy group; Simple clavicular region radiotherapy	Procedure: Simple clavicular region radiotherapy; If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclavicular recurrence free survival in group A patients	The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up.	5th year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival	The time from surgery to the occurrence of recurrence, metastasis, or last follow-up.	5th year after surgery
Intraclavicular recurrence free survival in group B patients	The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up	5th year after surgery
Regional lymph node recurrence free survival in group A/B patients	The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up	5th year after surgery
Overall survival of patients in Group A/B	The time from surgery to patient death or last follow-up	5th year after surgery
Number of adverse events	Complications related to surgery and radiotherapy	through study completion, an average of 2 year
The incidence of upper limb lymphedema in group A/B patients at 2 years after surgery	Measure the circumference using the circumference method, with the styloid process of the ulna as the starting point, spaced 10cm apart and measured up to 40cm.	2th year after surgery
Patient's quality of life	Evaluate using the EORTC-QLQ-C30 V3 （European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3）scale.EORTC-QLQ-C30 V3 is the core scale of the quality of life measurement system developed by the European Organization for Research and Treatment of Cancer (EORTC) for cancer patients. The original scores of each item in the scale need to be converted into standardized scores ranging from 0 to 100 using linear formulas. The higher the scores of each functional dimension, the better the functional status; The higher the score of the symptom scale and individual items, the more obvious the symptoms and the poorer the quality of life.	2th year after surgery

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Investigators: Study Chair: xiuchun Chen, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Estimated): April 4, 2027
• Study Completion (Estimated): April 4, 2027

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; Supraclavicular lymph node dissection
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2023-122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No