Breast Cancer23-01NCT00072293
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
A study testing Axillary lymph node dissection and No axillary lymph node dissection in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 31 sites in 10 countries.
Trial summary
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. 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?
- Axillary lymph node dissection and No axillary lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 931 participants
- Where
- 31 sitesin 10 countries
- Study dates
- Dec 2001to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
- Largest tumor lesion ≤ 5 cm
- Palpable or nonpalpable breast lesion
- Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions
- Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
- At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension
- No clinical evidence of distant metastases
- No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:
- Skeletal pain of unknown cause
- Elevated alkaline phosphatase
- Bone scan showing hot spots
- No palpable axillary lymph node(s)
- No Paget's disease without invasive cancer
- Hormone receptor status:
- Estrogen receptor and progesterone receptor known
PATIENT CHARACTERISTICS:
Age
- Any age
Sex
- Female
Menopausal status
- Any status
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- See Disease Characteristics
Renal
- Not specified
Other
- Not pregnant or nursing
- No other prior or concurrent malignancy except the following:
- Adequately treated basal cell or squamous cell skin cancer
- Adequately treated carcinoma in situ of the cervix
- Adequately treated in situ melanoma
- Contralateral or ipsilateral carcinoma in situ of the breast
- No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
- Geographically accessible for follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Other
- No prior systemic therapy for breast cancer
- More than 1 year since prior chemopreventive agent
Trial locations and contacts
31 sites in 10 countries.
31 sites in 10 countries
Australia10 sites
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia, 5000
St. John of God Hospital - Bunbury
Bunbury, Western Australia, 6230
Lismore Base Hospital
Lismore, New South Wales, 2480
St Vincents Hospital
Lismore, New South Wales, 2480
Mater Hospital - North Sydney
North Sydney, New South Wales, 2060
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, 2650
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, 2145
Italy8 sites
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
Ospedali Riuniti di Bergamo
Bergamo, 24100
University of Bologna Medical School
Bologna, 40138
Universita di Ferrara
Ferrara, 44100
Ospedale Alessandro Manzoni
Lecco, 23900
Istituto Scientifico H. San Raffaele
Milan, 20132
European Institute of Oncology
Milan, 20141
Fondazione Salvatore Maugeri
Pavia, I-27100
Switzerland5 sites
Kantonspital Aarau
Aarau, CH-5001
Oncology Institute of Southern Switzerland
Bellinzona, CH-6500
Inselspital Bern
Bern, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
New Zealand2 sites
North Shore Hospital
Auckland
Waikato Hospital
Hamilton, 2020
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.
PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.
Read the detailed description
OBJECTIVES:
- Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.
- Compare overall survival of patients treated with these regimens.
- Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.
- Assess long-term surgical complications in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.
- Conditions
- Breast Cancer
- Being tested
- Axillary lymph node dissection, No axillary lymph node dissection
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary lymph node dissectionProcedure or surgery
Axillary lymph node dissection
No axillary lymph node dissectionProcedure or surgery
Therapeutic conventional surgery
| Study group | Role | What they receive |
|---|---|---|
| Axillary Dissection | Active comparator | Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. Receives: Procedure: Axillary lymph node dissection |
| No Axillary Dissection | Experimental | Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. Receives: Procedure: No axillary lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Disease-Free Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.
Measured: 5-year estimate reported after a median follow-up of 60 months
Secondary outcomes (2)
5-year Overall Survival
Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.
Measured: 5-year estimate reported after a median follow-up of 60 months
Site of Recurrence
Site of recurrence of breast cancer
Measured: Reported after a median follow-up of 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startDec 2001
- Primary completionSep 2012
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 931 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Viviana E. Galimberti, Study chair, European Institute of OncologyUmberto Veronesi, MD, Prof., Study chair, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072293
- Sponsor's protocol ID
- CDR0000339581
- Other IDs
- IBCSG 23-01
- Acronym
- 23-01
- Status last verified
- Dec 2017
- First submitted
- 4 Nov 2003
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5.
PubMed 30196031Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11.
PubMed 23491275
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
- ClinicalTrials.gov ID
- NCT00072293
- Acronym / sponsor ID
- 23-01 / CDR0000339581
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 931 participants (actual)
- Lead sponsor
- ETOP IBCSG Partners FoundationResearch network
- Study start
- Dec 2001
- Primary completion
- Sep 2012 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 6 Nov 2003 (estimated)
- Results
- Posted 18 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.
PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.
Detailed description
OBJECTIVES:
- Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.
- Compare overall survival of patients treated with these regimens.
- Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.
- Assess long-term surgical complications in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary Dissection | Active comparator | Procedure: Axillary lymph node dissectionPatients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. |
| No Axillary Dissection | Experimental | Procedure: No axillary lymph node dissectionPatients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Axillary lymph node dissectionAxillary lymph node dissection | Procedure or surgery | Axillary Dissection |
| No axillary lymph node dissectionTherapeutic conventional surgery | Procedure or surgery | No Axillary Dissection |
Primary outcome
5-year Disease-Free Survival
Time frame: 5-year estimate reported after a median follow-up of 60 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.
2 secondary outcomes
5-year Overall Survival
Time frame: 5-year estimate reported after a median follow-up of 60 months
Site of Recurrence
Time frame: Reported after a median follow-up of 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30196031Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5.
- Derived from this study: PubMed 23491275Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11.
- Abstract from paper published in Lancet Oncology, 2013Link provided by the sponsor.
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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.
Viviana E. Galimberti study chair
European Institute of Oncology
Umberto Veronesi, MD, Prof. study chair
European Institute of Oncology
31 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary lymph node dissection and No axillary lymph node dissection in people with Breast Cancer, run by ETOP IBCSG Partners Foundation at 31 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Australia, Italy, Switzerland, New Zealand, Belgium and 5 more countries. 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?
Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
5-year Disease-Free Survival (time frame: 5-year estimate reported after a median follow-up of 60 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 NCT00072293, which also lists 2 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 23 Jan 2018; AzTrials last refreshed its copy on 28 Oct 2026.