Early Stage Breast CarcinomaSOUNDNCT02167490
Sentinel Node Vs Observation After Axillary Ultra-souND
A study testing Arm 1: sentinel node biopsy in people with Early Stage Breast Carcinoma, run by European Institute of Oncology at 18 sites in 4 countries.
Trial summary
The hypothesis of this trial are that: avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients pre-operative imaging of the axilla can identify… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Early Stage Breast Carcinoma
- What is being tested?
- Arm 1: sentinel node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Jan 2012to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- breast cancer <2 cm, and a clinically negative axilla
- any age
- candidates to receive breast conserving surgery + radiotherapy
- negative preoperative assessment of the axilla (ultra-sound with or without FNAC in case one doubtful node is found)
- written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- patients must be accessible for follow-up.
Who cannot join
- synchronous distant metastases
- previous malignancy
- bilateral breast cancer
- multicentric or multifocal breast cancer
- previous primary systemic therapy
- pregnancy or breastfeeding
Show all 9Show fewer
- pre-operative diagnosis (cytology or histology) of axillary lymph node metastases
- pre-operative radiological evidence of multiple involved or suspicious nodes
- patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Italy15 sites
Comprensorio Sanitario
Bolzano, 39100
Azienda Ospedaliera Spedali Civili
Brescia, 25123
Ospedale Oncologico Regionale
Cagliari, 09121
Humanitas Mater Domini
Castellanza
Ospedale S. Anna
Como, 22100
Azienda Ospedaliera Carlo Poma
Mantua, 46100
European Institute of Oncology
Milan, 20141
Fondazione IRCCS Istituto Nazionale Tumori
Milan, 20133
AOU Federico II
Naples, 80131
Istituto Nazionale Tumori
Naples, 80131
Ospedale San Matteo
Pavia
Ospedale Guglielmo di Saliceto
Piacenza, 29100
Ospedale Fatebenefratelli
Roma, 00186
Humanitas Cancer Center
Rozzano, 20089
Ospedale S. Anna
Torino, 10100
Switzerland1 site
Universitätsspital Bern Klinik und Poliklinik für Medizinische Onkologie
Bern
About this study
Official title: A Randomized Trial Comparing Sentinel Lymph Node Biopsy Vs no Axillary Surgical Staging in Patients With Small Breast Cancer and a Negative Preoperative Axillary Assessment (IEO S637/311)
The hypothesis of this trial are that:
- avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients
- pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden.
Read more
The aims of this prospective randomized study are:
- to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared
- to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status
- to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.
Read the detailed description
Sentinel lymph node biopsy (SLNB) is the standard approach for axillary staging in patients with breast cancer worldwide. The evident trend of breast cancer treatment is going towards minimizing axillary surgery, even in presence of involvement of the sentinel lymph node (SLN). In fact, it is well known that removal of lymph nodes is performed with staging purposes and to improve regional control but not with curative intent. Recent data from a prospective randomized trial which compared axillary dissection vs. no further axillary surgery in presence of positive SLN did not show any difference in term of overall and disease-free survival. Moreover, to date the impact of the prognostic information of axillary lymph node status in the decision-making process is less important than in the past as the adjuvant treatment is more and more tailored on the biological features of the disease rather than on the risk of recurrence.
This is a prospective randomized controlled trial in which patients with small breast cancer (T<2 cm), with a negative preoperative assessment of the axilla (ultra-sound with FNAC in presence of doubtful findings) will be randomized into two treatment arms:
- SLNB ± axillary dissection
- No axillary surgical staging In the arm 1, no axillary dissection will be performed in case of either negative SLN or in presence of isolated tumour cells or micrometastases. SLNB will be completed by axillary dissection in presence of macrometastases diagnosed in the SLN.
The aims of this prospective randomized study are:
to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.
Endpoints
The primary endpoint of the study is distant-disease free survival. This endpoint, a proxi of overall survival, will allow to have reliable results in a shorter period of time compared to overall survival.
Secondary endpoints will be the cumulative incidence of distant recurrences, the cumulative incidence of axillary recurrences, the disease free survival (DFS) and the overall survival (OS). Other secondary endpoints are quality of life and evaluation of type of adjuvant treatment administered.
Sample size calculation and statistical considerations
We will consider women who will undergo SLNB as the reference group, and we will test for non-inferiority the group of women not undergoing any treatment in the axilla. For the purpose of sample size calculation, the 5-year DDFS in the reference group is assumed to be 96.5%. Overall, 1560 women (780 per arm) will be enrolled to decide whether the group without treatment of the axilla is no worse than the reference group, given a margin delta of non-inferiority of 2.5% (maximum tolerable 5-years DDFS = 94%). Statistical power and one-sided type I error are set to 80% and 5%, respectively. After 3 years from the start of accrual an interim safety analysis will be performed.
Standard survival analyses and survival analyses with competing events will be performed. Multivariable Cox regression models will be applied to adjust the risk estimates of interest for other variables. The Chi-square test for trend, Chi-square test and the Fisher exact test will be used to evaluate differences in percentages between the two treatment groups, as appropriate. The T-tests will be used to evaluate differences in means for continuous variables.
- Conditions
- Early Stage Breast Carcinoma
- Being tested
- Arm 1: sentinel node biopsy
- Keywords
- BC; conservative surgery; SNB; AD; axillary US imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: sentinel node biopsyProcedure or surgery
Sentinel node biopsy policy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: sentinel node biopsy | Active comparator | Sentinel node biopsy policy Receives: Procedure: Arm 1: sentinel node biopsy |
| Arm 2: observation | No intervention | No axillary staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant-disease free survival
Measured: 6 months
Secondary outcomes (4)
Cumulative incidence of distant recurrences
Measured: 6 months
Cumulative incidence of axillary recurrences
Measured: 6 months
Disease free survival (DFS)
Measured: 6 months
Overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oreste D Gentilini, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167490
- Sponsor's protocol ID
- IEO S637/311
- Acronym
- SOUND
- Status last verified
- Nov 2024
- First submitted
- 18 Apr 2014
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V, Intra M, Veronesi P, Robertson C, Maisonneuve P, Renne G, De Cicco C, De Lucia F, Gennari R. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003 Aug 7;349(6):546-53. doi: 10.1056/NEJMoa012782.
PubMed 12904519Veronesi U, Galimberti V, Paganelli G, Maisonneuve P, Viale G, Orecchia R, Luini A, Intra M, Veronesi P, Caldarella P, Renne G, Rotmensz N, Sangalli C, De Brito Lima L, Tullii M, Zurrida S. Axillary metastases in breast cancer patients with negative sentinel nodes: a follow-up of 3548 cases. Eur J Cancer. 2009 May;45(8):1381-8. doi: 10.1016/j.ejca.2008.11.041. Epub 2009 Jan 6.
PubMed 19128957Wasif N, Maggard MA, Ko CY, Giuliano AE. Underuse of axillary dissection for the management of sentinel node micrometastases in breast cancer. Arch Surg. 2010 Feb;145(2):161-6. doi: 10.1001/archsurg.2009.269.
PubMed 20157084Galimberti V, Botteri E, Chifu C, Gentilini O, Luini A, Intra M, Baratella P, Sargenti M, Zurrida S, Veronesi P, Rotmensz N, Viale G, Sonzogni A, Colleoni M, Veronesi U. Can we avoid axillary dissection in the micrometastatic sentinel node in breast cancer? Breast Cancer Res Treat. 2012 Feb;131(3):819-25. doi: 10.1007/s10549-011-1486-2. Epub 2011 Apr 6.
PubMed 21468637Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.
PubMed 20739842Giuliano 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 21304082Fisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002 Aug 22;347(8):567-75. doi: 10.1056/NEJMoa020128.
PubMed 12192016International Breast Cancer Study Group; Rudenstam CM, Zahrieh D, Forbes JF, Crivellari D, Holmberg SB, Rey P, Dent D, Campbell I, Bernhard J, Price KN, Castiglione-Gertsch M, Goldhirsch A, Gelber RD, Coates AS. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol. 2006 Jan 20;24(3):337-44. doi: 10.1200/JCO.2005.01.5784. Epub 2005 Dec 12.
PubMed 16344321Veronesi U, Orecchia R, Zurrida S, Galimberti V, Luini A, Veronesi P, Gatti G, D'Aiuto G, Cataliotti L, Paolucci R, Piccolo P, Massaioli N, Sismondi P, Rulli A, Lo Sardo F, Recalcati A, Terribile D, Acerbi A, Rotmensz N, Maisonneuve P. Avoiding axillary dissection in breast cancer surgery: a randomized trial to assess the role of axillary radiotherapy. Ann Oncol. 2005 Mar;16(3):383-8. doi: 10.1093/annonc/mdi089. Epub 2005 Jan 24.
PubMed 15668261Goldhirsch A, Ingle JN, Gelber RD, Coates AS, Thurlimann B, Senn HJ; Panel members. Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009. Ann Oncol. 2009 Aug;20(8):1319-29. doi: 10.1093/annonc/mdp322. Epub 2009 Jun 17.
PubMed 19535820Colleoni M, Rotmensz N, Peruzzotti G, Maisonneuve P, Mazzarol G, Pruneri G, Luini A, Intra M, Veronesi P, Galimberti V, Torrisi R, Cardillo A, Goldhirsch A, Viale G. Size of breast cancer metastases in axillary lymph nodes: clinical relevance of minimal lymph node involvement. J Clin Oncol. 2005 Mar 1;23(7):1379-89. doi: 10.1200/JCO.2005.07.094.
PubMed 15735114Montagna E, Viale G, Rotmensz N, Maisonneuve P, Galimberti V, Luini A, Intra M, Veronesi P, Mazzarol G, Pruneri G, Renne G, Torrisi R, Cardillo A, Cancello G, Goldhirsch A, Colleoni M. Minimal axillary lymph node involvement in breast cancer has different prognostic implications according to the staging procedure. Breast Cancer Res Treat. 2009 Nov;118(2):385-94. doi: 10.1007/s10549-009-0446-6. Epub 2009 Jun 27.
PubMed 19562480Hansen NM, Grube B, Ye X, Turner RR, Brenner RJ, Sim MS, Giuliano AE. Impact of micrometastases in the sentinel node of patients with invasive breast cancer. J Clin Oncol. 2009 Oct 1;27(28):4679-84. doi: 10.1200/JCO.2008.19.0686. Epub 2009 Aug 31.
PubMed 19720928Korn EL, Hunsberger S, Freidlin B, Smith MA, Abrams JS. Preliminary data release for randomized clinical trials of noninferiority: a new proposal. J Clin Oncol. 2005 Aug 20;23(24):5831-6. doi: 10.1200/JCO.2005.02.105. Epub 2005 Jul 18.
PubMed 16027441Marubini E, Valsecchi MG. Analysing survival data from clinical trials and observational studies. Chichester, England: Wiley; 1995. 331 pp.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Sentinel Lymph Node Biopsy Vs no Axillary Surgical Staging in Patients With Small Breast Cancer and a Negative Preoperative Axillary Assessment (IEO S637/311)
- ClinicalTrials.gov ID
- NCT02167490
- Acronym / sponsor ID
- SOUND / IEO S637/311
- Conditions
- Early Stage Breast Carcinoma
- Keywords
- BC; conservative surgery; SNB; AD; axillary US imaging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Jun 2014 (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.
The hypothesis of this trial are that:
- avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients
- pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden.
The aims of this prospective randomized study are:
- to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared
- to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status
- to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.
Detailed description
Sentinel lymph node biopsy (SLNB) is the standard approach for axillary staging in patients with breast cancer worldwide. The evident trend of breast cancer treatment is going towards minimizing axillary surgery, even in presence of involvement of the sentinel lymph node (SLN). In fact, it is well known that removal of lymph nodes is performed with staging purposes and to improve regional control but not with curative intent. Recent data from a prospective randomized trial which compared axillary dissection vs. no further axillary surgery in presence of positive SLN did not show any difference in term of overall and disease-free survival. Moreover, to date the impact of the prognostic information of axillary lymph node status in the decision-making process is less important than in the past as the adjuvant treatment is more and more tailored on the biological features of the disease rather than on the risk of recurrence.
This is a prospective randomized controlled trial in which patients with small breast cancer (T<2 cm), with a negative preoperative assessment of the axilla (ultra-sound with FNAC in presence of doubtful findings) will be randomized into two treatment arms:
- SLNB ± axillary dissection
- No axillary surgical staging In the arm 1, no axillary dissection will be performed in case of either negative SLN or in presence of isolated tumour cells or micrometastases. SLNB will be completed by axillary dissection in presence of macrometastases diagnosed in the SLN.
The aims of this prospective randomized study are:
to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.
Endpoints
The primary endpoint of the study is distant-disease free survival. This endpoint, a proxi of overall survival, will allow to have reliable results in a shorter period of time compared to overall survival.
Secondary endpoints will be the cumulative incidence of distant recurrences, the cumulative incidence of axillary recurrences, the disease free survival (DFS) and the overall survival (OS). Other secondary endpoints are quality of life and evaluation of type of adjuvant treatment administered.
Sample size calculation and statistical considerations
We will consider women who will undergo SLNB as the reference group, and we will test for non-inferiority the group of women not undergoing any treatment in the axilla. For the purpose of sample size calculation, the 5-year DDFS in the reference group is assumed to be 96.5%. Overall, 1560 women (780 per arm) will be enrolled to decide whether the group without treatment of the axilla is no worse than the reference group, given a margin delta of non-inferiority of 2.5% (maximum tolerable 5-years DDFS = 94%). Statistical power and one-sided type I error are set to 80% and 5%, respectively. After 3 years from the start of accrual an interim safety analysis will be performed.
Standard survival analyses and survival analyses with competing events will be performed. Multivariable Cox regression models will be applied to adjust the risk estimates of interest for other variables. The Chi-square test for trend, Chi-square test and the Fisher exact test will be used to evaluate differences in percentages between the two treatment groups, as appropriate. The T-tests will be used to evaluate differences in means for continuous variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: sentinel node biopsy | Active comparator | Procedure: Arm 1: sentinel node biopsySentinel node biopsy policy |
| Arm 2: observation | No intervention | –No axillary staging |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- breast cancer <2 cm, and a clinically negative axilla
- any age
- candidates to receive breast conserving surgery + radiotherapy
- negative preoperative assessment of the axilla (ultra-sound with or without FNAC in case one doubtful node is found)
- written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Key exclusion criteria (9 listed)
- synchronous distant metastases
- previous malignancy
- bilateral breast cancer
- multicentric or multifocal breast cancer
- previous primary systemic therapy
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 |
|---|---|---|
| Arm 1: sentinel node biopsySentinel node biopsy policy | Procedure or surgery | Arm 1: sentinel node biopsy |
Primary outcome
Distant-disease free survival
Time frame: 6 months
4 secondary outcomes
Cumulative incidence of distant recurrences
Time frame: 6 months
Cumulative incidence of axillary recurrences
Time frame: 6 months
Disease free survival (DFS)
Time frame: 6 months
Overall survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Background: PubMed 12904519Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V, Intra M, Veronesi P, Robertson C, Maisonneuve P, Renne G, De Cicco C, De Lucia F, Gennari R. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003 Aug 7;349(6):546-53. doi: 10.1056/NEJMoa012782.
- Background: PubMed 19128957Veronesi U, Galimberti V, Paganelli G, Maisonneuve P, Viale G, Orecchia R, Luini A, Intra M, Veronesi P, Caldarella P, Renne G, Rotmensz N, Sangalli C, De Brito Lima L, Tullii M, Zurrida S. Axillary metastases in breast cancer patients with negative sentinel nodes: a follow-up of 3548 cases. Eur J Cancer. 2009 May;45(8):1381-8. doi: 10.1016/j.ejca.2008.11.041. Epub 2009 Jan 6.
- Background: PubMed 20157084Wasif N, Maggard MA, Ko CY, Giuliano AE. Underuse of axillary dissection for the management of sentinel node micrometastases in breast cancer. Arch Surg. 2010 Feb;145(2):161-6. doi: 10.1001/archsurg.2009.269.
- Background: PubMed 21468637Galimberti V, Botteri E, Chifu C, Gentilini O, Luini A, Intra M, Baratella P, Sargenti M, Zurrida S, Veronesi P, Rotmensz N, Viale G, Sonzogni A, Colleoni M, Veronesi U. Can we avoid axillary dissection in the micrometastatic sentinel node in breast cancer? Breast Cancer Res Treat. 2012 Feb;131(3):819-25. doi: 10.1007/s10549-011-1486-2. Epub 2011 Apr 6.
- Background: PubMed 20739842Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.
- 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.
- Background: PubMed 12192016Fisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002 Aug 22;347(8):567-75. doi: 10.1056/NEJMoa020128.
- Background: PubMed 16344321International Breast Cancer Study Group; Rudenstam CM, Zahrieh D, Forbes JF, Crivellari D, Holmberg SB, Rey P, Dent D, Campbell I, Bernhard J, Price KN, Castiglione-Gertsch M, Goldhirsch A, Gelber RD, Coates AS. Randomized trial comparing axillary clearance versus no axillary clearance in older patients with breast cancer: first results of International Breast Cancer Study Group Trial 10-93. J Clin Oncol. 2006 Jan 20;24(3):337-44. doi: 10.1200/JCO.2005.01.5784. Epub 2005 Dec 12.
- Background: PubMed 15668261Veronesi U, Orecchia R, Zurrida S, Galimberti V, Luini A, Veronesi P, Gatti G, D'Aiuto G, Cataliotti L, Paolucci R, Piccolo P, Massaioli N, Sismondi P, Rulli A, Lo Sardo F, Recalcati A, Terribile D, Acerbi A, Rotmensz N, Maisonneuve P. Avoiding axillary dissection in breast cancer surgery: a randomized trial to assess the role of axillary radiotherapy. Ann Oncol. 2005 Mar;16(3):383-8. doi: 10.1093/annonc/mdi089. Epub 2005 Jan 24.
- Background: PubMed 19535820Goldhirsch A, Ingle JN, Gelber RD, Coates AS, Thurlimann B, Senn HJ; Panel members. Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009. Ann Oncol. 2009 Aug;20(8):1319-29. doi: 10.1093/annonc/mdp322. Epub 2009 Jun 17.
- Background: PubMed 15735114Colleoni M, Rotmensz N, Peruzzotti G, Maisonneuve P, Mazzarol G, Pruneri G, Luini A, Intra M, Veronesi P, Galimberti V, Torrisi R, Cardillo A, Goldhirsch A, Viale G. Size of breast cancer metastases in axillary lymph nodes: clinical relevance of minimal lymph node involvement. J Clin Oncol. 2005 Mar 1;23(7):1379-89. doi: 10.1200/JCO.2005.07.094.
- Background: PubMed 19562480Montagna E, Viale G, Rotmensz N, Maisonneuve P, Galimberti V, Luini A, Intra M, Veronesi P, Mazzarol G, Pruneri G, Renne G, Torrisi R, Cardillo A, Cancello G, Goldhirsch A, Colleoni M. Minimal axillary lymph node involvement in breast cancer has different prognostic implications according to the staging procedure. Breast Cancer Res Treat. 2009 Nov;118(2):385-94. doi: 10.1007/s10549-009-0446-6. Epub 2009 Jun 27.
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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.
Oreste D Gentilini, MD principal investigator
European Institute of Oncology
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: sentinel node biopsy in people with Early Stage Breast Carcinoma, run by European Institute of Oncology at 18 sites in 4 countries.
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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, Chile, Spain, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Distant-disease free survival (time frame: 6 months). 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 NCT02167490, which also lists 18 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 25 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.