Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer

NCT03716245 | Completed

• 1 other identifier: SCLND0919
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. No concret guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis. To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, the investigators randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.

Conditions

Breast Cancer Stage III

Keywords

breast cancer; supraclavicular lymph node; dissection; radiotherpy; prognosis

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Disease free survival for 3 years and 5 years, which means the rate of patients without local recurrence and distant metastasis in the whole patients at the same group will be calculated with Kaplan Meier survival curves.

  3-5 years

Secondary Outcomes (4)

• Occurring rate of complications

  3-5 years

• Overall survival

  3-5 years

• Life quality score

  3-5 years

• Recurrence free survival

  3-5 years

Study Arms (2)

supraclavicular lymph node dissection and raidiotherapy

EXPERIMENTAL

breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular lymph node dissection and supraclavicular area radiotherapy

Procedure: supraclavicular lymph node dissection

supraclavicular area radiotherapy

ACTIVE COMPARATOR

breast cancer patients with supraclavicular lymph node metastasis receive supraclavicular area radiotherapy

Radiation: supraclavicular area radiotherapy

Interventions

supraclavicular lymph node dissection PROCEDURE

people with supraclavicular lymph node metastasis before surgery should receive dissection of supraclavicular lymph node and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy

supraclavicular lymph node dissection and raidiotherapy

supraclavicular area radiotherapy RADIATION

people with supraclavicular lymph node metastasis before surgery should receive radiotherapy of supraclavicular area and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy

supraclavicular area radiotherapy

Eligibility Criteria

• Age: Up to 75 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
• Age≤75 years old, female;
• Histologically confirmed breast cancer;
• Histologically or cytologically confirmed ipsilateral supraclavicular lymph node metastasis；
• cT0-T3；
• low and moderate risk for anesthesia

You may not qualify if:

• Absolute and relative contraindication for surgery or radiation；
• existing distant metastasis before surgery；
• non-invasive breast cancer；
• with contralateral breast cancer；
• Previous history of breast cancer or other malignancies；
• ECOG≥2；
• inflammatory breast cancer；
• pregnancy；
• any serious complications which caused patients not suitable to participate this study

Sponsors & Collaborators

• Xinhong Wu, PhD: lead

Study Sites (1)

Wu Xinhong

Wuhan, Hubei, 430079, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Xinhong Wu, Doctor

  Hubei Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 23, 2018
• Study Start: February 27, 2019
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)