Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000024448
Ethics application status
Approved
Date submitted
12/05/1999
Date registered
12/05/1999
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
IBCSG 10-93 - Surgical therapy with or without axillary node clearance for breast cancer in the elderly who receive adjuvant therapy with Tamoxifen
Scientific title
Surgical therapy with or without axillary node clearance for breast cancer in the elderly who receive adjuvant therapy with Tamoxifen
Secondary ID [1] 19 0
National Clinical Trials Registry: NCTR304
Secondary ID [2] 287872 0
NCT00002528
Universal Trial Number (UTN)
Trial acronym
IBCSG-10-93
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 18 0
Condition category
Condition code
Cancer 18 18 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Either a total mastectomy with axillary clearance (removal of the axillary lymph nodes), or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection followed by Tamoxifen (20mg orally daily) for the duration of 5 years or until relapse.

Arm B: either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection followed by Tamoxifen (20mg orally daily) for the duration of 5 years or until relapse.
Intervention code [1] 1294 0
Treatment: Surgery
Comparator / control treatment
See above "Description of interventions".
Control group
Active

Outcomes
Primary outcome [1] 33 0
Risk of recurrence in the axilla
Timepoint [1] 33 0
Patients will be assessed by the clinician for the primary endpoints every 3 months for the first year on study, every 6 months while receiving tamoxifen and annually thereafter for life.
Primary outcome [2] 34 0
Disease free survival
Timepoint [2] 34 0
Patients will be assessed by the clinician for the primary endpoints every 3 months for the first year on study, every 6 months while receiving tamoxifen and annually thereafter for life.
Secondary outcome [1] 55 0
Overall survival
Timepoint [1] 55 0
Patients will be assessed by the clinician for the secondary endpoints every 3 months for the first year on study, every 6 months while receiving tamoxifen and annually thereafter for life.
Secondary outcome [2] 56 0
Sites of Relapse
Timepoint [2] 56 0
Patients will be assessed by the clinician for the secondary endpoints every 3 months for the first year on study, every 6 months while receiving tamoxifen and annually thereafter for life.
Secondary outcome [3] 57 0
Treatment-related side effects.
Timepoint [3] 57 0
Patients will be assessed by the clinician for the secondary endpoints every 3 months for the first year on study, every 6 months while receiving tamoxifen and annually thereafter for life.
Patients will be assessed by the clinician for the secondary endpoints every 3 months for the first year on study, every 6 months while receiving tamoxifen and annually thereafter for life.
Secondary outcome [4] 58 0
Quality of Life
Timepoint [4] 58 0
Will also be measured every 3 months during the first year on study, every 6 months until year 5 and then once again at year 6.

Eligibility
Key inclusion criteria
Postmenopausal • Clinically operable breast cancer, clinically N0, diagnosed either by cytology or histology, and are before axillary clearance. • No definitive surgery and no axillary clearance performed.• Complete excisional biopsy without axillary clearance• Tumour confined to the breast with no detected or suspected metastases • Informed consent• Geographically accessible for follow-up• Completion of baseline quality of life assessment.
Minimum age
60 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Already undergone definitive surgery with axillary clearance or an axillary biopsy only.• Patients who have malignant breast tumours other than carcinoma• Patients with clinically N1 or N2 lymph nodes• Patients who have T4 inflammatory carcinoma with ulceration or infiltration of skin, with peau d’orange, or clinical appearance of axillary involvement.• Bilateral malignancy, except patients with squamous or basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix• Have receive prior therapy for breast cancer including irradiation, surgery, chemotherapy and /or hormonal therapy.• Non-malignant systemic disease which prevent them from being subject to any of the treatment options or prolonged follow up• Psychiatric or addictive disorders• Have bone scintigrams showing hot spots or skeletal pain which cannot be confirmed as benign disease.

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)
Central randomisation by phone
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
Completed
Date of first participant enrolment
Anticipated
1/05/1993
Actual
23/11/1993
Date of last participant enrolment
Anticipated
Actual
1/12/2002
Date of last data collection
Anticipated
Actual
Sample size
Target
1020
Accrual to date
Final
473
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 24 0
Self funded/Unfunded
Name [1] 24 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 24 0
Australia
Primary sponsor type
Other Collaborative groups
Name
International Breast Cancer Study Group
Address
Effingerstrasse 40, 3008 Bern
Country
Switzerland
Secondary sponsor category [1] 22 0
Other Collaborative groups
Name [1] 22 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 22 0
PO BOX 155
HRMC NSW 2310
Country [1] 22 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 254 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [1] 254 0
Ethics committee country [1] 254 0
Australia
Date submitted for ethics approval [1] 254 0
Approval date [1] 254 0
Ethics approval number [1] 254 0
Ethics committee name [2] 255 0
Caboolture Hospital
Ethics committee address [2] 255 0
Ethics committee country [2] 255 0
Australia
Date submitted for ethics approval [2] 255 0
Approval date [2] 255 0
Ethics approval number [2] 255 0
Ethics committee name [3] 256 0
Alfred Hospital
Ethics committee address [3] 256 0
Ethics committee country [3] 256 0
Australia
Date submitted for ethics approval [3] 256 0
Approval date [3] 256 0
Ethics approval number [3] 256 0
Ethics committee name [4] 257 0
Royal Melbourne Hospital
Ethics committee address [4] 257 0
Ethics committee country [4] 257 0
Australia
Date submitted for ethics approval [4] 257 0
Approval date [4] 257 0
Ethics approval number [4] 257 0
Ethics committee name [5] 258 0
St Vincent's Hospital, Melbourne
Ethics committee address [5] 258 0
Ethics committee country [5] 258 0
Australia
Date submitted for ethics approval [5] 258 0
Approval date [5] 258 0
01/05/1993
Ethics approval number [5] 258 0
Ethics committee name [6] 259 0
Western Hospital
Ethics committee address [6] 259 0
Ethics committee country [6] 259 0
Australia
Date submitted for ethics approval [6] 259 0
Approval date [6] 259 0
Ethics approval number [6] 259 0
Ethics committee name [7] 260 0
St John of God Hospital, Subiaco
Ethics committee address [7] 260 0
Ethics committee country [7] 260 0
Australia
Date submitted for ethics approval [7] 260 0
Approval date [7] 260 0
Ethics approval number [7] 260 0
Ethics committee name [8] 261 0
Waikato Hospital
Ethics committee address [8] 261 0
Ethics committee country [8] 261 0
New Zealand
Date submitted for ethics approval [8] 261 0
Approval date [8] 261 0
Ethics approval number [8] 261 0

Summary
Brief summary
It is unclear whether patients who do not undergo an axillary dissection and receive further systemic treatment, have a similar prognosis to those with axillary clearance who receive the same therapy. The focus of this international trial is to determine the importance of an axillary node dissection for breast cancer patients 60 years or older who receive Tamoxifen as an ongoing treatment. Particular attention will also be given to the quality of life of the patients over the first six years of the study.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 36210 0
Prof John F Forbes
Address 36210 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 36210 0
Australia
Phone 36210 0
+ 61 2 4985 0113
Fax 36210 0
Email 36210 0
enquiries@anzbctg.org
Contact person for public queries
Name 10483 0
Ms Corinna Beckmore
Address 10483 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10483 0
Australia
Phone 10483 0
+61 2 4925 3068
Fax 10483 0
+61 2 4985 0141
Email 10483 0
enquiries@anzbctg.org
Contact person for scientific queries
Name 1411 0
Prof John F Forbes
Address 1411 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1411 0
Australia
Phone 1411 0
+ 61 2 4985 0113
Fax 1411 0
+ 61 2 4960 1539
Email 1411 0
enquiries@anzbctg.org

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

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