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

Last updated: September 18, 2024
Sponsor: Henan Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Simple clavicular region radiotherapy

Subclavian lymph node dissection+radiotherapy

Clinical Study ID

NCT06605521
2023-122
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 invasivebreast cancer, known ER, PR, HER2, KI67 status, pathologically diagnosed asipsilateral supraclavicular lymph node metastasis (both cytology andhistopathology);

  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 nonintervention studies) at the same time and are judged by the researchers not toaffect the research protocol can be enrolled normally.

  8. Voluntarily participate in this study and sign an informed consent form.

Exclusion

Exclusion Criteria:

  1. Stage IV (metastatic) breast cancer;

  2. Bilateral breast cancer;

  3. Received radiotherapy and surgical treatment (excluding local puncture) foripsilateral supraclavicular metastatic lymph nodes before enrollment;

  4. History of breast cancer or other malignant tumors, but excluding cured cervicalcarcinoma 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 havingother acquired or congenital immunodeficiency diseases, or having a history of organtransplantation;

  7. Suffering from severe comorbidities or other comorbidities that may interfere withthe planned treatment, or any other circumstances in which the researcher deems thepatient unsuitable to participate in this study.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Simple clavicular region radiotherapy
Phase:
Study Start date:
April 04, 2023
Estimated Completion Date:
April 04, 2027

Study 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.

Connect with a study center

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.