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

NCT06605521 | Recruiting

• 1 other identifier: 2023-122
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Locally Advanced Breast Cancer

Keywords

Supraclavicular lymph node dissection; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Disease-Free Survival

  5th year after surgery

• Intraclavicular recurrence free survival in group B patients

  5th year after surgery

• Regional lymph node recurrence free survival in group A/B patients

  5th year after surgery

• Overall survival of patients in Group A/B

  5th year after surgery

• Number of adverse events

  through study completion, an average of 2 year

Study Arms (2)

Subclavian lymph node dissection+radiotherapy group

Subclavian lymph node dissection+radiotherapy

Procedure: Subclavian lymph node dissection+radiotherapy

Simple clavicular region radiotherapy group

Simple clavicular region radiotherapy

Procedure: Simple clavicular region radiotherapy

Interventions

Subclavian lymph node dissection+radiotherapy PROCEDURE

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.

Also known as: experimental group

Subclavian lymph node dissection+radiotherapy group

Simple clavicular region radiotherapy PROCEDURE

If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.

Also known as: control group

Simple clavicular region radiotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cT1-4N3M0 breast cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• xiuchun Chen

  Henan Cancer Hospital

  STUDY CHAIR

Central Study Contacts

xiuchun Chen

CONTACT

0371-65587405; zlyychenxiuchun3921@zzu.edu.cn

Minhao Lv

CONTACT

0371-65587405; zlyylvminhao2789@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: September 20, 2024
• Study Start: April 4, 2023
• Primary Completion (Estimated): April 4, 2027
• Study Completion (Estimated): April 4, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-02

Locations

CN (1)