Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06383663

Supraclavicular Lymph Node Dissection for Ipsilateral Supraclavicular Lymph Node Metastatic Breast Cancer

The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

In this study, patients with ipsilateral supraclavicular lymph node positive breast cancer were selected as research subjects. Randomized controlled method was used to study the effects of surgical dissection of supraclavicular lymph node combined with radiotherapy and radiotherapy alone on progression-free survival and overall survival of breast cancer. This RCT aims to explore the best treatment method for ipsilateral supraclavicular lymph node metastasis and to provide the basis for guiding the precise treatment of supraclavicular lymph node chain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously untreated primary breast cancer with supraclavicular lymph node metastasis or supraclavicular lymph node metastasis without other metastasis within 5 years after combined therapy; The diagnostic criteria refer to the diagnostic criteria for "primary breast cancer" and "Stage pN3c" in the AJCC Guidelines published on November 8, 2018;
  • Supraclavicular lymph node metastasis was confirmed by pathology;
  • Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
  • Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
  • Have at least one measurable target lesion according to RECIST criteria;
  • ECOG score ≦ 1;
  • The level of organ function must meet the following requirements: adequate bone marrow reserve: absolute counts of neutrophils (lobed and band neutrophils) ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. Liver: Bilirubin <1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 times the upper limit of normal. Renal: Creatinine clearance ≥ 45 mL/min;
  • No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;
  • normal mind, can cooperate to complete the treatment;
  • Expected survival ≥36 months
  • In accordance with the requirements of the Ethics Committee, there is an informed consent signed by the patient or her legal representative, or an informed consent signed by the patient and her family.

Exclusion criteria

  • The range of metastasis exceeds the neck IV and VB region;
  • En-bloc resection cannot be achieved;
  • Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy;
  • Preoperative examination found distant metastasis;
  • Pregnant, lactating or inflammatory breast cancer patients;
  • Diseases associated with immune, endocrine or cardiovascular systems;
  • Previous history of other tumors or combined with other tumors;
  • Refusing to comply with the study protocol and refusing to sign the informed consent

Treatment and study plan

Supraclavicular lymph node dissection combined with radiotherapy

Procedure

Breast cancer patients in the expreimental cohort with only ipsilateral supraclavicular lymph node metastasis were first treated with supraclavicular lymph node dissection and received standard radiotherapy after surgery.

Radiotherapy

Radiation

Patients in the control group received only standard radiation therapy.

Primary outcomes

  1. DFS

    Time frame: 5-year

    Disease-free survival

Secondary outcomes

  1. PFS

    Time frame: 3-year

    Progression-free survival

  2. OS

    Time frame: 5-year

    Overall survival

Other outcomes

  1. pCR rate

    Time frame: 1-year

    Pathological complete response rate

Study contacts

Contact information is provided by the study sponsor or research team.

Weidong Wei, Professor

CONTACT

[email protected]

+8613822278328

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Prospective Multicenter Randomized Controlled Trial of the Prognostic Effects of Supraclavicular Lymph Node Dissection vs. No-dissection in Ipsilateral Supraclavicular Lymph Node Metastasis in Breast Cancer

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Apr 25, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.