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

Official 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

Overview

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.

Detailed 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.

Interventions

• Procedure Supraclavicular lymph node dissection combined with radiotherapy
  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.
• Radiation radiotherapy
  Patients in the control group received only standard radiation therapy.

Primary outcome measures

• DFS [Time frame: 5-year]

Secondary outcome measures (2)

• PFS [Time frame: 3-year]
• OS [Time frame: 5-year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Recht A, Gray R, Davidson NE, Fowble BL, Solin LJ, Cummings FJ, Falkson G, Falkson HC, Taylor SG 4th, Tormey DC. Locoregional failure 10 years after mastectomy and adjuvant chemotherapy with or without tamoxifen without irradiation: experience of the Eastern Cooperative Oncology Group. J Clin Oncol. 1999 Jun;17(6):1689-700. doi: 10.1200/JCO.1999.17.6.1689. PMID 10561205
• Chen SC, Chen MF, Hwang TL, Chao TC, Lo YF, Hsueh S, Chang JT, Leung WM. Prediction of supraclavicular lymph node metastasis in breast carcinoma. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):614-9. doi: 10.1016/s0360-3016(01)02680-3. PMID 11849781
• Chang XZ, Yin J, Sun J, Zhang XH, Cao XC. A retrospective study of different local treatments in breast cancer patients with synchronous ipsilateral supraclavicular lymph node metastasis. J Cancer Res Ther. 2013 Nov;9 Suppl:S158-61. doi: 10.4103/0973-1482.122514. PMID 24516053
• Jung J, Kim SS, Ahn SD, Lee SW, Ahn SH, Son BH, Lee JW, Choi EK. Treatment Outcome of Breast Cancer with Pathologically Proven Synchronous Ipsilateral Supraclavicular Lymph Node Metastases. J Breast Cancer. 2015 Jun;18(2):167-72. doi: 10.4048/jbc.2015.18.2.167. Epub 2015 Jun 26. PMID 26155293
• Lakatos E. Designing complex group sequential survival trials. Stat Med. 2002 Jul 30;21(14):1969-89. doi: 10.1002/sim.1193. PMID 12111882

Identifiers

NCT: NCT06383663 · 308-2019-04-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗