Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by National Institute of Oncology, Hungary
Sponsor:
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier:
NCT01804309
First received: March 1, 2013
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

Regional lymph node status is the most important prognostic factor for disease-free and overall survival in breast cancer. Accurate nodal staging can be achieved only by surgery. Today, in early-stage invasive breast cancers with clinically negative lymph nodes, minimally invasive sentinel lymph node biopsy (SLNB) is considered the gold standard of regional lymph node staging. To optimize the effectiveness of SLNB, precise pre-and intraoperative mapping of lymphatic drainage is important. The (SLNB) technique is not standardized. The most common and most accurate way of lymphatic mapping is performed with the combined application of a gamma-emitting isotope labeled substance and blue dye, the so-called double labeling technique. Functional lymphatic drainage of SLNB double staining in the mammary gland, skin and axilla present a number of uncertainties.

According to the axillary, lateral thoracic and thoracodorsal veins, Ibusuki et al. divided the axillary region into four subregions: brachial (lateral), pectoral (anterior), central and subscapular (posterior) zones. They revealed clear relationship between the anatomic location and status of the SLN, also confirmed by Gallowitsch et al. SLN was detected in Level I in 96% and in Level II in 4% by SPECT/CT.

Knowedge of relationships between the drainage of sentinel lymph node staining into the axillary subregions, location of the primary tumor, tumor size, SLN positivity and its location within the subregion are of particular importance in the decision making whether or not axillary lymphadenectomy (ALND) needs to be performed.

In the prospective randomized phase 3 trial by Giuliano et al. (ACOSOG Z-11) ALND was not performed in early breast cancer patients with clinically negative axilla and breast-conserving surgery, for 1-2 macroscopically positive SLNs (10). After an average follow-up of 6.3 years, data were compared to the traditional ALND group and no difference was detected in 5-year overall survival or disease-free survival at 5 years.

Aims of the investigation:

To examine the location of SLN in the axillary subregion (anterior, posterior, central, lateral, apical) in patients with early breast cancer (T <5 cm).

To statistically assess correlations between the location, size, histological parameters of primary breast tumor and the subregion of the SLN.

To statistically assess SLN positivity and its location within the sbregion.

To statistically assess subregional localisation of positive SLN and the number of all positive regional lymph nodes, to predict a limited number of cases with lymph node metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be omitted.


Condition Intervention
Breast Cancer
Procedure: Sentinel lymph node biopsy (SLNB)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Institute of Oncology, Hungary:

Primary Outcome Measures:
  • The assessment of any correlations between the subregional location of SLNs within the axillary trench and the clinical-pathological parameters of the tumor. [ Time Frame: Specimen is processed within 2-4 weeks in pathology. Average time frame maximum: 3 weeks following surgical intervention. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The assessment of any correlations between the subregional location of positive SLNs within the axillary trench and the number of all positive axillary lymph nodes. [ Time Frame: Same as for primary outcome measure. ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Early breast cancer patients
Clinical stage T1-2 N0M0 primary unilateral invasive breast cancer patients
Procedure: Sentinel lymph node biopsy (SLNB)
The intervention (SLNB) is no different in the care of patients' in the study then in those who were not included in the past or will not be included after the trial terminates. SLNB is performed according to strict professional guidelines adopted by the National Institute of Oncology, Budapest, Hungary.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinical stage T1-2(≤ 5cm)N0M0 primary unilateral invasive breast cancer patients

Criteria

Inclusion Criteria:

  • women with clinically node negative invasive or microinvasive breast cancer: T1-2(≤ 5cm)N0M0
  • 18 years of age or older

Exclusion Criteria:

  • previous ALND
  • clinically positive axillary SLNB
  • pregnant or lactating
  • neoadjuvant breast cancer treatment based on surgeon's discretion (ASCO)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804309

Contacts
Contact: Bence Dorogi, MD +36 1 224 8600 dorogibence@gmail.com

Locations
Hungary
National Institute of Oncology Recruiting
Budapest, Hungary, 1122
Contact: Bence Dorogi, MD    +36 1 224 8600    dorogibence@gmail.com   
Principal Investigator: Zoltán Mátrai, MD, PhD, FEBS         
Sub-Investigator: László Tóth, MD, PhD         
Sub-Investigator: Bence Dorogi, MD         
Sub-Investigator: Zoltán Sulyok, MD         
Sub-Investigator: Emil Farkas, MD         
Sub-Investigator: Ákos Sávolt, MD         
Sub-Investigator: László Góbor, MD         
Sponsors and Collaborators
National Institute of Oncology, Hungary
Investigators
Principal Investigator: Zoltán Mátrai, MD, PhD, FEBS National Institute of Oncology
Study Director: Bence Dorogi, MD National Institute of Oncology
  More Information

Publications:

Responsible Party: Dr. Zoltan Matrai, head of the Dept. of Breast and Sarcoma Surgery, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT01804309     History of Changes
Other Study ID Numbers: FANTON-Ebc
Study First Received: March 1, 2013
Last Updated: March 13, 2013
Health Authority: Hungary: Institutional Ethics Committee

Keywords provided by National Institute of Oncology, Hungary:
axyllary lymph node
sentinel lymph node
lymphatic drainage
early breast cancer
axillary lymph node dissection

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014