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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Breast Cancer; Ipsilateral Supraclavicular Lymph Node Metastasis

Treatments: Procedure: Supraclavicular lymph node dissection combined with radiotherapy; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06383663

308-2019-04-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 452 estimated patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Supraclavicular lymph node metastasis was confirmed by pathology;
3. Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
4. Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
5. Have at least one measurable target lesion according to RECIST criteria;
6. ECOG score ≦ 1;
7. 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;
8. No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;
9. normal mind, can cooperate to complete the treatment;
10. Expected survival ≥36 months
11. 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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452 participants in 2 patient groups, including a placebo group

Supraclavicular lymph node dissection combined with radiotherapy

Experimental group

Description:

Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive standard radiotherapy after supraclavicular lymph node dissection.

Treatment:

Procedure: Supraclavicular lymph node dissection combined with radiotherapy

radiotherapy

Placebo Comparator group

Description:

Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive only standard radiotherapy.

Treatment:

Radiation: radiotherapy