Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000360617
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
9/09/2005
Date last updated
12/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
IBCSG 23-01 Sentinel Node Biopsy Trial
Scientific title
A randomised 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] 152 0
National Clinical Trials Registry: NCTR565
Universal Trial Number (UTN)
Trial acronym
IBCSG 23-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adjuvant Breast Cancer 455 0
Condition category
Condition code
Cancer 531 531 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial is being conducted internationally by the International Breast Cancer Study Group. The trial is co-ordinated in Australia and New Zealand by Breast Cancer Trials (formerly the Australia & New Zealand Breast Cancer Trials Group). The aim of this clinical trial is to try to determine whether long term survival for women who do not have an axillary dissection is different from women who do have an axillary dissection when the sentinel lymph node contains micrometastases. IBCSG 23-01 is an international, multicentre, randomised clinical trial of 1960 patients with histologically proven, clinically node-negative breast cancer who have undergone primary breast surgery and sentinel node biopsy with micrometastases identified in the sentinel node. Women will be randomised in a 2-arm design to receive one of the following: a. Axillary dissection b. No axillary dissection
Intervention code [1] 427 0
Diagnosis / Prognosis
Comparator / control treatment
No axillary dissection
Control group
Historical

Outcomes
Primary outcome [1] 612 0
Disease-free survival (DFS) - defined as the time from randomisation to local (including recurrence restricted to the breast after breast conserving treatment), regional (including reappearance of tumour in the undissected axilla), or distant recurrence, appearance of a second contralateral breast primary, appearance of a second non-breast primary, or death from any cause, whichever occurs first. An in situ recurrence either in the ipsilateral or in the contralateral breast is not considered a recurrence.
Timepoint [1] 612 0
DFS will be assessed as follows: assessed as follows: within one month of randomisation, every 4 months during Year 1, every 6 months during Years 2-5 and yearly thereafter until death or trial closure. Analysis of the increase in the hazards ratio of no axillary dissection versus axillary dissection will be conducted after 558 events have been observed. This is anticipated to occur approximately 11.84 years from the start of the study or in January 2013. Three interim analyses will be conducted , one at 25% of the target number of events, one at 50% of the target number of events and at 75% of the target number of events.
Secondary outcome [1] 1278 0
Overall survival (OS) - defined as the time from randomisation to death from any cause.
Timepoint [1] 1278 0
Overall survival will be analysed as per the primary outcome timepoint and assessed as follows: within one month of randomisation, every 4 months during Year 1, every 6 months during Years 2-5 and yearly thereafter until death or trial closure.
Secondary outcome [2] 9011 0
Systemic disease-free survival - defined as the time from randomisation to systemic relapse, appearance of second (non-breast)primary tumour, or death, whichever occurs first. (Systemic relapse is defined as any recurrent or metastatic disease in sites other that the local mastectomy scar/chest wall/skin, the ipsilateral breast in case of breast conservation, or the contralateral breast)
Timepoint [2] 9011 0
Systemic disease-free survival will be analysed as per the primary outcome timepoint and assessed as follows: within one month of randomisation, every 4 months during Year 1, every 6 months during Years 2-5 and yearly thereafter until death or trial closure.
Secondary outcome [3] 9012 0
Quality of life - measured using patient self-assessments
Timepoint [3] 9012 0
Quality of life will be analysed as per the primary outcome timepoint and assessed as follows: at registration, every 4 months from date of randomisation during Year 1, every 6 months during Years 2-5 and at 6years (72 months).
Secondary outcome [4] 9013 0
Incidence of reappearance of disease in the undissected axilla
Timepoint [4] 9013 0
Incidence of reappearance of disease in the undissected axilla will be analysed as per the primary outcome timepoint and assessed as follows: within one month of randomisation, every 4 months during Year 1, every 6 months during Years 2-5 and yearly thereafter until death or trial closure.
Secondary outcome [5] 9014 0
Sites of first failure - include: local, regional, conralateral breast and distant failures, second (non-breast) primaries and deaths without recurrence.
Timepoint [5] 9014 0
Sites of first failure will be analysed as per the primary outcome timepoint and assessed as follows: within one month of randomisation, every 4 months during Year 1, every 6 months during Years 2-5 and yearly thereafter until death or trial closure.
Secondary outcome [6] 9015 0
Long term surgical complications eg Sensory neuropathy, lymphedema and motor neuropathy will be assessed by the physician and graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC VERSION 2). Assessments will occur within one month of randomisation, every 4 months during Year 1 and every 6 months during Years 2-5
Timepoint [6] 9015 0
Long term surgical complications eg Sensory neuropathy, lymphedema and motor neuropathy will be assessed by the physician and graded according to the NCI Common Toxicity Criteria (CTC VERSION 2). Assessments will occur within one month of randomisation, every 4 months during Year 1 and every 6 months during Years 2-5

Eligibility
Key inclusion criteria
Patients of any age with pathological diagnosis of unifocal breast carcinoma with micrometastases in the sentinel node, who have completed baseline Quality of Life evaluations, and geographically accessible for follow up and who have signed written informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with clinical evidence of distant metastases; palpable axillary nodes; Pagets disease without invasive cancer; patients who have received a chemoprevention agent within a year of randomization; patients who are pregnant or lactating; patients with previous or concomitant malignancy.

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)
The ANZ BCTG Statistical Centre at the NHMRC Clinical Trials Centre, University of Sydney will provide a central registration/randomisation service by fax for all Australian and New Zealand institutions. At the time of study entry all participants will be allocated to either axillary node dissection or no axillary node dissection via a web-based randomization system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Much lower than expected event rate; continuing recruitment will not provide meaningful information to address the randomised study question.
Date of first participant enrolment
Anticipated
11/11/2005
Actual
2/03/2006
Date of last participant enrolment
Anticipated
Actual
28/02/2010
Date of last data collection
Anticipated
31/12/2020
Actual
31/03/2017
Sample size
Target
1960
Accrual to date
Final
934
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment outside Australia
Country [1] 9233 0
New Zealand
State/province [1] 9233 0
N/A

Funding & Sponsors
Funding source category [1] 590 0
Self funded/Unfunded
Name [1] 590 0
ANZ Breast Cancer Trials Group
Country [1] 590 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 479 0
Other Collaborative groups
Name [1] 479 0
International Breast Cancer Study Group
Address [1] 479 0
IBCSG Coordinating Center
Effingerstrasse 40
3008 Bern
SWITZERLAND
Country [1] 479 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293828 0
Riverina Cancer Care Centre HREC
Ethics committee address [1] 293828 0
31 Meurant Avenue
Wagga Wagga NSW 2650
Ethics committee country [1] 293828 0
Australia
Date submitted for ethics approval [1] 293828 0
31/10/2005
Approval date [1] 293828 0
11/11/2005
Ethics approval number [1] 293828 0
IBCSG 23-01

Summary
Brief summary
Breast cancer usually first spreads to lymph nodes in the axilla (armpit). Sentinel node biopsy is a way of finding and removing the lymph nodes most likely to contain cancer. Women found to have cancer in their sentinel nodes usually undergo an axillary clearance. This involves removal of most lymph nodes in the armpit but can cause side effects such as lymphoedema (arm swelling) and other problems. This international phase III trial will determine if an axillary clearance is warranted for women who have only small clumps of cancer cells, called micrometastases, found in the sentinel lymph nodes.
Trial website
www.breastcancertrials.org.au
Trial related presentations / publications
Public notes
Breast Cancer Trials formerly the Australia & New Zealand Breast Cancer Trials Group.

Contacts
Principal investigator
Name 35542 0
A/Prof John Collins
Address 35542 0
Royal Melbourne Hospital
Country 35542 0
Australia
Phone 35542 0
+61 (03) 9349-4688
Fax 35542 0
Email 35542 0
[email protected]
Contact person for public queries
Name 9616 0
Ms Corinna Beckmore
Address 9616 0
BCT
PO Box 283
The Junction NSW 2291
Country 9616 0
Australia
Phone 9616 0
+61 2 4925 5235
Fax 9616 0
+61 2 4925 3068
Email 9616 0
[email protected]
Contact person for scientific queries
Name 544 0
Prof John F Forbes
Address 544 0
BCT
PO Box 283
The Junction NSW 2291
Country 544 0
Australia
Phone 544 0
+61 2 4925 5235
Fax 544 0
+61 2 4925 3068
Email 544 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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