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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00072293




Registration number
NCT00072293
Ethics application status
Date submitted
4/11/2003
Date registered
6/11/2003
Date last updated
23/01/2018

Titles & IDs
Public title
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Scientific 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
Secondary ID [1] 0 0
IBCSG 23-01
Secondary ID [2] 0 0
CDR0000339581
Universal Trial Number (UTN)
Trial acronym
23-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Axillary lymph node dissection
Treatment: Surgery - No axillary lymph node dissection

Active comparator: Axillary Dissection - Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.

Experimental: No Axillary Dissection - Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.


Treatment: Surgery: Axillary lymph node dissection
Axillary lymph node dissection

Treatment: Surgery: No axillary lymph node dissection
Therapeutic conventional surgery
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year Disease-Free Survival
Timepoint [1] 0 0
5-year estimate reported after a median follow-up of 60 months
Secondary outcome [1] 0 0
5-year Overall Survival
Timepoint [1] 0 0
5-year estimate reported after a median follow-up of 60 months
Secondary outcome [2] 0 0
Site of Recurrence
Timepoint [2] 0 0
Reported after a median follow-up of 60 months

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2017
Sample size
Target
Accrual to date
Final
931
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [2] 0 0
St Vincents Hospital - Lismore
Recruitment hospital [3] 0 0
Mater Hospital - North Sydney - North Sydney
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [5] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [7] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Royal Adelaide Hospital Cancer Centre - Adelaide
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
St. John of God Hospital - Bunbury - Bunbury
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6230 - Bunbury
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Liege
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio Grande Do Sul
Country [3] 0 0
Denmark
State/province [3] 0 0
Horsholm
Country [4] 0 0
France
State/province [4] 0 0
Villejuif
Country [5] 0 0
Italy
State/province [5] 0 0
Aviano
Country [6] 0 0
Italy
State/province [6] 0 0
Bergamo
Country [7] 0 0
Italy
State/province [7] 0 0
Bologna
Country [8] 0 0
Italy
State/province [8] 0 0
Ferrara
Country [9] 0 0
Italy
State/province [9] 0 0
Lecco
Country [10] 0 0
Italy
State/province [10] 0 0
Milan
Country [11] 0 0
Italy
State/province [11] 0 0
Pavia
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Hamilton
Country [14] 0 0
Peru
State/province [14] 0 0
Lima
Country [15] 0 0
Slovenia
State/province [15] 0 0
Ljubljana
Country [16] 0 0
Switzerland
State/province [16] 0 0
Aarau
Country [17] 0 0
Switzerland
State/province [17] 0 0
Bellinzona
Country [18] 0 0
Switzerland
State/province [18] 0 0
Bern
Country [19] 0 0
Switzerland
State/province [19] 0 0
Lausanne
Country [20] 0 0
Switzerland
State/province [20] 0 0
St. Gallen

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/study/NCT00072293
Trial related presentations / 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.
Galimberti 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. Erratum In: Lancet Oncol. 2013 Jun;14(7):e254.
Public notes

Contacts
Principal investigator
Name 0 0
Viviana E. Galimberti
Address 0 0
European Institute of Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00072293