Breast CancerNCT01804309
Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer
An observational study of Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel lymph node biopsy (SLNB)
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Clinical stage T1-2(≤ 5cm)N0M0 primary unilateral invasive breast cancer patients
Who may be able to join
- women with clinically node negative invasive or microinvasive breast cancer: T1-2(≤ 5cm)N0M0
- 18 years of age or older
Who cannot join
- previous ALND
- clinically positive axillary SLNB
- pregnant or lactating
- neoadjuvant breast cancer treatment based on surgeon's discretion (ASCO)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Sentinel lymph node biopsy (SLNB)
- Keywords
- axyllary lymph node, sentinel lymph node, lymphatic drainage, early breast cancer, axillary lymph node dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsy (SLNB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Early breast cancer patients | Clinical stage T1-2 N0M0 primary unilateral invasive breast cancer patients Receives: Procedure: Sentinel lymph node biopsy (SLNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of any correlations between the subregional location of SLNs within the axillary trench and the clinical-pathological parameters of the tumor.
Measured: Specimen is processed within 2-4 weeks in pathology. Average time frame maximum: 3 weeks following surgical intervention.
Secondary outcomes (1)
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.
Measured: Same as for primary outcome measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Oncology, Hungary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zoltan Matrai, National Institute of Oncology, Hungary
- Investigators
- Zoltán Mátrai, MD, PhD, FEBS, Principal investigator, National Institute of OncologyBence Dorogi, MD, Study director, National Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804309
- Sponsor's protocol ID
- FANTON-Ebc
- Status last verified
- Oct 2015
- First submitted
- 1 Mar 2013
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1200/JCO.2000.18.13.2553.
PubMed 10893286Matrai Z, Toth L, Saeki T, Sinkovics I, Godeny M, Takeuchi H, Bidlek M, Bartal A, Savolt A, Dorogi B, Kasler 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.
PubMed 21464026Ibusuki 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.
PubMed 19442515Gallowitsch 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.
PubMed 18084680Giuliano 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.
PubMed 21304082
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01804309
- Acronym / sponsor ID
- FANTON-Ebc
- Conditions
- Breast Cancer
- Keywords
- axyllary lymph node, sentinel lymph node, lymphatic drainage, early breast cancer, axillary lymph node dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- National Institute of Oncology, HungaryUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early breast cancer patients | – | Procedure: Sentinel lymph node biopsy (SLNB)Clinical stage T1-2 N0M0 primary unilateral invasive breast cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical stage T1-2(≤ 5cm)N0M0 primary unilateral invasive breast cancer patients
Key inclusion criteria (2 listed)
- women with clinically node negative invasive or microinvasive breast cancer: T1-2(≤ 5cm)N0M0
- 18 years of age or older
Key exclusion criteria (4 listed)
- previous ALND
- clinically positive axillary SLNB
- pregnant or lactating
- neoadjuvant breast cancer treatment based on surgeon's discretion (ASCO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Early breast cancer patients |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Background: PubMed 10893286Giuliano 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. doi: 10.1200/JCO.2000.18.13.2553.
- Background: PubMed 21464026Matrai Z, Toth L, Saeki T, Sinkovics I, Godeny M, Takeuchi H, Bidlek M, Bartal A, Savolt A, Dorogi B, Kasler 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.
- Background: PubMed 19442515Ibusuki 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.
- Background: PubMed 18084680Gallowitsch 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.
- Background: PubMed 21304082Giuliano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoltán Mátrai, MD, PhD, FEBS principal investigator
National Institute of Oncology
Bence Dorogi, MD study director
National Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804309, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.