Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000037404
Ethics application status
Approved
Date submitted
3/11/1994
Date registered
3/11/1994
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
IBCSG VIII - Adjuvant therapy in pre- and peri-menopausal patients with node negative breast cancer
Scientific title
Adjuvant therapy in pre- and peri-menopausal patients with node negative breast cancer
Secondary ID [1] 7 0
National Clinical Trials Registry: NCTR58
Universal Trial Number (UTN)
Trial acronym
IBCSG VIII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 10 0
Condition category
Condition code
Cancer 10 10 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B: Luteinising hormone- releasing hormone (LH-RH) analogue - Zoladex (3.6 mg subcutaneous injection every 28 days) x 24 months
Arm C: CMF x 6 months (Cyclophosphamide (100mg/m^2 orally days 1-14), Methotrexate (40mg/m^2 iv – days 1 & 8) and 5-Fluorouracil (600mg/m^2iv – days 1 & 8))
Arm D: CMF x 6 months (Cyclophosphamide (100mg/m^2 orally days 1-14), Methotrexate (40mg/m^2 iv – days 1 & 8) and 5-Fluorouracil (600mg/m^2 iv – days 1 & 8)) followed by LH-RH analogue (Zoladex – 3.6 mg subcutatneous injection every 28 days) x 18 months
Intervention code [1] 1280 0
Treatment: Drugs
Comparator / control treatment
Arm A: No adjuvant therapy (arm discontinued 2/04/1992)
Control group
Active

Outcomes
Primary outcome [1] 13 0
The primary endpoint for evaluation of therapeutic effect will be disease-free survival (DFS) where all relapses, second primary tumours and death without recurrence are counted as failures.
Timepoint [1] 13 0
Patients are followed up and assessed in clinic after every CMF and LH-RH (lutenising hormone-releasing hormone) analogue administration. Follow-up is required ever third month during the first two years, every six months for the next three years and yearly thereafter for life.
Secondary outcome [1] 18 0
Overall survival
Timepoint [1] 18 0
Patients are followed up and assessed in clinic after every CMF and LH-RH (lutenising hormone-releasing hormone) analogue administration. Follow-up is required ever third month during the first two years, every six months for the next three years and yearly thereafter for life.
Secondary outcome [2] 19 0
Patterns of relapse
Timepoint [2] 19 0
Patients are followed up and assessed in clinic after every CMF and LH-RH (lutenising hormone-releasing hormone) analogue administration. Follow-up is required ever third month during the first two years, every six months for the next three years and yearly thereafter for life.
Secondary outcome [3] 20 0
Treatment-related side effects will also be assessed.
Timepoint [3] 20 0
Patients are followed up and assessed in clinic after every CMF and LH-RH (lutenising hormone-releasing hormone) analogue administration. Follow-up is required ever third month during the first two years, every six months for the next three years and yearly thereafter for life.
Secondary outcome [4] 21 0
Systemic disease-free survival.
Timepoint [4] 21 0
Will be monitored at regular intervals (6 monthly Data Safety and Monitoring Committee Meetings) for possible early termination of patient entry.

Eligibility
Key inclusion criteria
• Node negative disease• Patients must have had:a) Either total mastectomy or breast-conserving procedureb) Axillary clearance with at least 8 lymph nodes for pathological examinationc) The surgical procedure within 6 weeks prior to randomisation• At least 8 lymph nodes histo-pathologically examined• Tumour confirmed to breast with no detected metastases• Adequate marrow function• Documented evidence of adequate renal and hepatic function• Informed consent• Pre- and perimenopausal patients: a) > 52 years, and have had LNMP (last normal menstrual period) within 1 year; orb) < or equal to 52 years, and have had the LNMP within 3 years, or are currently menstruating; orc) < or equal to 55 years and have had hysterectomy without bilateral oophorectomy; ord) Biochemical confirmation of continuing ovarian function
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Axillary node involvement• Malignant breast tumours other than carcinoma• T4 tumours with ulceration or infiltration of the skin, peau d'orange, or metastatic disease• Bilateral malignancies, or mass in opposite breast, unless mass is proven by biopsy to be non-malignant• Patients who have had less than total mastectomy procedure in which margins of resection contained tumour cells, after which they did not subsequently undergo a total mastectomy • Pregnant at diagnosis or lactating patients (including those who have stopped lactating within past 6 months)• Previous or concurrent malignancy, except patients with squamous or basal cell carcinoma of skin, or adequately treated in-situ carcinoma of cervix• Prior therapy for breast cancer, including irradiation, surgery or chemo- and/or hormonal therapy• Other non-malignant systemic diseases preventing treatment options or prolonged follow-up• Psychiatric or addictive disorders preventing informed consent or treatment options• Bone scan showing hot spots which cannot be confirmed as benign disease or skeletal pain of unknown cause• Older than 45 years who have had a hysterectomy, unless there is chemical proof of ovarian function by all of the following tests: Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), Oestradiol (E2) (Addendum 1 – 1/11/1991)• Estrogen receptor negative tumours or who are estrogen receptor status unknown (Addendum 7 - 1/08/1998)

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 and fax
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
N/A
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/1990
Actual
29/05/1990
Date of last participant enrolment
Anticipated
Actual
1/10/1999
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
1111
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 11 0
Self funded/Unfunded
Name [1] 11 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 11 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] 10 0
Other Collaborative groups
Name [1] 10 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 10 0
PO BOX 155
HRMC NSW 2310
Country [1] 10 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 63 0
Dubbo Base Hospital
Ethics committee address [1] 63 0
Ethics committee country [1] 63 0
Australia
Date submitted for ethics approval [1] 63 0
Approval date [1] 63 0
Ethics approval number [1] 63 0
Ethics committee name [2] 64 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [2] 64 0
Ethics committee country [2] 64 0
Australia
Date submitted for ethics approval [2] 64 0
Approval date [2] 64 0
Ethics approval number [2] 64 0
Ethics committee name [3] 65 0
Prince of Wales Hospital
Ethics committee address [3] 65 0
Ethics committee country [3] 65 0
Australia
Date submitted for ethics approval [3] 65 0
Approval date [3] 65 0
Ethics approval number [3] 65 0
Ethics committee name [4] 66 0
Royal Prince Alfred Hospital
Ethics committee address [4] 66 0
Ethics committee country [4] 66 0
Australia
Date submitted for ethics approval [4] 66 0
Approval date [4] 66 0
Ethics approval number [4] 66 0
Ethics committee name [5] 67 0
Flinders Medical Centre
Ethics committee address [5] 67 0
Ethics committee country [5] 67 0
Australia
Date submitted for ethics approval [5] 67 0
Approval date [5] 67 0
Ethics approval number [5] 67 0
Ethics committee name [6] 68 0
Royal Adelaide Hospital
Ethics committee address [6] 68 0
Ethics committee country [6] 68 0
Australia
Date submitted for ethics approval [6] 68 0
Approval date [6] 68 0
Ethics approval number [6] 68 0
Ethics committee name [7] 69 0
Launceston General Hospital
Ethics committee address [7] 69 0
Ethics committee country [7] 69 0
Australia
Date submitted for ethics approval [7] 69 0
Approval date [7] 69 0
Ethics approval number [7] 69 0
Ethics committee name [8] 70 0
Albury Base Hospital
Ethics committee address [8] 70 0
Ethics committee country [8] 70 0
Australia
Date submitted for ethics approval [8] 70 0
Approval date [8] 70 0
Ethics approval number [8] 70 0
Ethics committee name [9] 71 0
Alfred Hospital
Ethics committee address [9] 71 0
Ethics committee country [9] 71 0
Australia
Date submitted for ethics approval [9] 71 0
Approval date [9] 71 0
Ethics approval number [9] 71 0
Ethics committee name [10] 72 0
Austin Health
Ethics committee address [10] 72 0
Ethics committee country [10] 72 0
Australia
Date submitted for ethics approval [10] 72 0
Approval date [10] 72 0
Ethics approval number [10] 72 0
Ethics committee name [11] 73 0
Bendigo Hospital
Ethics committee address [11] 73 0
Ethics committee country [11] 73 0
Australia
Date submitted for ethics approval [11] 73 0
Approval date [11] 73 0
Ethics approval number [11] 73 0
Ethics committee name [12] 74 0
Box Hill Hospital
Ethics committee address [12] 74 0
Ethics committee country [12] 74 0
Australia
Date submitted for ethics approval [12] 74 0
Approval date [12] 74 0
Ethics approval number [12] 74 0
Ethics committee name [13] 75 0
Geelong Hospital
Ethics committee address [13] 75 0
Ethics committee country [13] 75 0
Australia
Date submitted for ethics approval [13] 75 0
Approval date [13] 75 0
Ethics approval number [13] 75 0
Ethics committee name [14] 76 0
Royal Melbourne Hospital
Ethics committee address [14] 76 0
Ethics committee country [14] 76 0
Australia
Date submitted for ethics approval [14] 76 0
Approval date [14] 76 0
01/03/1990
Ethics approval number [14] 76 0
Ethics committee name [15] 77 0
St Vincent's Hospital, Melbourne
Ethics committee address [15] 77 0
Ethics committee country [15] 77 0
Australia
Date submitted for ethics approval [15] 77 0
Approval date [15] 77 0
Ethics approval number [15] 77 0
Ethics committee name [16] 78 0
Western Hospital
Ethics committee address [16] 78 0
Ethics committee country [16] 78 0
Australia
Date submitted for ethics approval [16] 78 0
Approval date [16] 78 0
Ethics approval number [16] 78 0
Ethics committee name [17] 79 0
Auckland Hospital
Ethics committee address [17] 79 0
Ethics committee country [17] 79 0
New Zealand
Date submitted for ethics approval [17] 79 0
Approval date [17] 79 0
Ethics approval number [17] 79 0

Summary
Brief summary
IBCSG VIII is a randomised clinical trial designed to test the therapeutic role of short duration ovarian function suppression (using Zoladex) in pre-/perimenopausal patients with node negative breast cancer.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 35676 0
Prof John F Forbes
Address 35676 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35676 0
Australia
Phone 35676 0
+61 2 4985 0113
Fax 35676 0
Email 35676 0
[email protected]
Contact person for public queries
Name 10469 0
Corinna Beckmore
Address 10469 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10469 0
Australia
Phone 10469 0
+61 2 4925 3068
Fax 10469 0
+61 2 4985 0141
Email 10469 0
[email protected]
Contact person for scientific queries
Name 1397 0
John F Forbes
Address 1397 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1397 0
Australia
Phone 1397 0
+61 2 4925 5235
Fax 1397 0
+ 61 2 4960 1539
Email 1397 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
SourceTitleYear of PublicationDOI
Dimensions AIPrognostic interaction between expression of p53 and estrogen receptor in patients with node-negative breast cancer: results from IBCSG Trials VIII and IX2012https://doi.org/10.1186/bcr3348
N.B. These documents automatically identified may not have been verified by the study sponsor.