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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804309
• Other study ID #: FANTON-Ebc
• Status: Completed
• Phase: N/A
• First received: March 1, 2013
• Last updated: October 5, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: National Institute of Oncology, Hungary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Hungary	National Institute of Oncology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Oncology, Hungary

Country where clinical trial is conducted

Hungary, 

References & Publications (5)

Gallowitsch HJ, Kraschl P, Igerc I, Hussein T, Kresnik E, Mikosch P, Kohlfuerst S, Hausegger K, Lind P. Sentinel node SPECT-CT in breast cancer. Can we expect any additional and clinically relevant information? Nuklearmedizin. 2007;46(6):252-6. — View Citation

Giuliano AE, Haigh PI, Brennan MB, Hansen NM, Kelley MC, Ye W, Glass EC, Turner RR. Prospective observational study of sentinel lymphadenectomy without further axillary dissection in patients with sentinel node-negative breast cancer. J Clin Oncol. 2000 Jul;18(13):2553-9. Erratum in: J Clin Oncol 2000 Nov 15;18(22):3877. — View Citation

Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90. — View Citation

Ibusuki M, Yamamoto Y, Kawasoe T, Shiraishi S, Tomiguchi S, Yamashita Y, Honda Y, Iyama K, Iwase H. Potential advantage of preoperative three-dimensional mapping of sentinel nodes in breast cancer by a hybrid single photon emission CT (SPECT)/CT system. Surg Oncol. 2010 Jun;19(2):88-94. doi: 10.1016/j.suronc.2009.04.001. Epub 2009 May 12. — View Citation

Mátrai Z, Tóth L, Saeki T, Sinkovics I, Godény M, Takeuchi H, Bidlek M, Bartal A, Sávolt A, Dorogi B, Kásler M. [The potential role of SPECT/CT in the preoperative detection of sentinel lymph nodes in breast cancer]. Orv Hetil. 2011 Apr 24;152(17):678-88. doi: 10.1556/OH.2011.29077. Hungarian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The assessment of any correlations between the subregional location of SLNs within the axillary trench and the clinical-pathological parameters of the tumor.		Specimen is processed within 2-4 weeks in pathology. Average time frame maximum: 3 weeks following surgical intervention.	No
Secondary	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.		Same as for primary outcome measure.	No