Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000029493
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 IX - Adjuvant therapy in postmenopausal patients with node negative breast cancer
Scientific title
Adjuvant therapy in postmenopausal patients with node negative breast cancer
Secondary ID [1] 8 0
National Clinical Trials Registry: NCTR92
Universal Trial Number (UTN)
Trial acronym
IBCSG IX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 8 0
Condition category
Condition code
Cancer 8 8 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B: CMF (cyclophosphamide 100mg /m^2 orally days 1-14, Methotrexate i.v. 40mg/m^2 days 1 and 8 and 5-Fluorouracil i.v. 600mg/m^2 days 1 and 8) for three cycles (cycle duration is 28 days) followed by Tamoxifen (20mg orally daily for 57months – addendum 3). Combined this gives a total duration of treatment of 60 months.
Intervention code [1] 1283 0
Treatment: Drugs
Comparator / control treatment
Arm A: Tamoxifen (20mg orally daily for 60 months – addendum 3)
Control group
Active

Outcomes
Primary outcome [1] 14 0
Disease-free survival (DFS) where all relapses, second primary tumours and deaths without recurrence are counted as failures.
Timepoint [1] 14 0
Patients are assessed for disease status every 3 months during the first year on study, every 6 months during year 2 and annually thereafter for life.
Secondary outcome [1] 22 0
Overall survival
Timepoint [1] 22 0
Patients are assessed for survival, treatment-related side effects and systemic recurrence at each chemotherapy cycle administration, every 3 months during the first year on study, every 6 months during year 2 and annually thereafter for life.
Secondary outcome [2] 23 0
Patterns of relapse
Timepoint [2] 23 0
Patterns of relapse will be reviewed by the Data Safety and Monitoring Committee at semi-annual meetings.
Secondary outcome [3] 24 0
Treatment-related side effects
Timepoint [3] 24 0
Patients are assessed for survival, treatment-related side effects and systemic recurrence at each chemotherapy cycle administration, every 3 months during the first year on study, every 6 months during year 2 and annually thereafter for life.
Secondary outcome [4] 25 0
Systemic disease-free survival
Timepoint [4] 25 0
Will be monitored for the duration of the trial for possible early termination of patient entry.
Secondary outcome [5] 26 0
Quality of Life
Timepoint [5] 26 0
Quality of Life is assessed every 3 months during the first year on study, every 6 months during year 2 and annually until year 6.

Eligibility
Key inclusion criteria
Postmenopausal women who are:a) > 52 years, with at least 1 year amenorrhea; orb) < or equal to 52 years with 3 or more years of amenorrhea; or c) > 55 years and have had hysterectomy without bilateral oophorectomy; ord) Biochemical evidence of cessation of ovarian function (in questionable cases)Patients must have had:a. Either total mastectomy, or breast conserving procedure (lumpectomy or quadrantectomy)b. Axillary clearance with at least 8 lymph nodes for pathological examinationc. Surgical procedure within 6 weeks prior to randomisation• Node negative disease (without metastases detected at pathologic examination in at least 8 ipsilateral axillary nodes)• Eight lymph nodes histopathologically examined• Tumour confined to breast with no detected metastases• Adequate marrow function (WBC > 400/mm3 and platelets > 100,000/mm3• Documented evidence of adequate renal (creatinine < 120umol/l) and hepatic (bilirubin < 20umol/l, SGOT < 60 IU/l) function• Informed consent
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 skin, peau d' orange, or metastatic disease• Bilateral malignancies, or mass in opposite breast, unless mass is proven by biopsy to be non-malignant• Less than total mastectomy procedure in which margins of resection contained tumour cells, after which they did not subsequently undergo total mastectomy• Premenopausal patients• Previous or concurrent malignancy, except patients with squamous or basal cell carcinoma of skin, or 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• Estrogen receptor negative tumours or are oestrogen receptor status unknown (addendum 12).

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
1/10/1988
Actual
3/04/1989
Date of last participant enrolment
Anticipated
Actual
1/08/1999
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
1715
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 9 0
Self funded/Unfunded
Name [1] 9 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 9 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] 8 0
Other Collaborative groups
Name [1] 8 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 8 0
PO BOX 155
HRMC NSW 2310
Country [1] 8 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 80 0
Dubbo Base Hospital
Ethics committee address [1] 80 0
Ethics committee country [1] 80 0
Australia
Date submitted for ethics approval [1] 80 0
Approval date [1] 80 0
01/10/1988
Ethics approval number [1] 80 0
Ethics committee name [2] 81 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [2] 81 0
Ethics committee country [2] 81 0
Australia
Date submitted for ethics approval [2] 81 0
Approval date [2] 81 0
Ethics approval number [2] 81 0
Ethics committee name [3] 82 0
Prince of Wales Hospital
Ethics committee address [3] 82 0
Ethics committee country [3] 82 0
Australia
Date submitted for ethics approval [3] 82 0
Approval date [3] 82 0
Ethics approval number [3] 82 0
Ethics committee name [4] 83 0
Royal Prince Alfred Hospital
Ethics committee address [4] 83 0
Ethics committee country [4] 83 0
Australia
Date submitted for ethics approval [4] 83 0
Approval date [4] 83 0
Ethics approval number [4] 83 0
Ethics committee name [5] 84 0
Sydney Adventist Hospital
Ethics committee address [5] 84 0
Ethics committee country [5] 84 0
Australia
Date submitted for ethics approval [5] 84 0
Approval date [5] 84 0
Ethics approval number [5] 84 0
Ethics committee name [6] 85 0
Flinders Medical Centre
Ethics committee address [6] 85 0
Ethics committee country [6] 85 0
Australia
Date submitted for ethics approval [6] 85 0
Approval date [6] 85 0
Ethics approval number [6] 85 0
Ethics committee name [7] 86 0
Royal Adelaide Hospital
Ethics committee address [7] 86 0
Ethics committee country [7] 86 0
Australia
Date submitted for ethics approval [7] 86 0
Approval date [7] 86 0
Ethics approval number [7] 86 0
Ethics committee name [8] 87 0
Austin Health
Ethics committee address [8] 87 0
Ethics committee country [8] 87 0
Australia
Date submitted for ethics approval [8] 87 0
Approval date [8] 87 0
Ethics approval number [8] 87 0
Ethics committee name [9] 88 0
Bendigo Hospital
Ethics committee address [9] 88 0
Ethics committee country [9] 88 0
Australia
Date submitted for ethics approval [9] 88 0
Approval date [9] 88 0
Ethics approval number [9] 88 0
Ethics committee name [10] 89 0
Box Hill Hospital
Ethics committee address [10] 89 0
Ethics committee country [10] 89 0
Australia
Date submitted for ethics approval [10] 89 0
Approval date [10] 89 0
Ethics approval number [10] 89 0
Ethics committee name [11] 90 0
Geelong Hospital
Ethics committee address [11] 90 0
Ethics committee country [11] 90 0
Australia
Date submitted for ethics approval [11] 90 0
Approval date [11] 90 0
Ethics approval number [11] 90 0
Ethics committee name [12] 91 0
Monash Medical Centre
Ethics committee address [12] 91 0
Ethics committee country [12] 91 0
Australia
Date submitted for ethics approval [12] 91 0
Approval date [12] 91 0
Ethics approval number [12] 91 0
Ethics committee name [13] 92 0
Peter MacCallum Cancer Centre
Ethics committee address [13] 92 0
Ethics committee country [13] 92 0
Australia
Date submitted for ethics approval [13] 92 0
Approval date [13] 92 0
Ethics approval number [13] 92 0
Ethics committee name [14] 93 0
Royal Melbourne Hospital
Ethics committee address [14] 93 0
Ethics committee country [14] 93 0
Australia
Date submitted for ethics approval [14] 93 0
Approval date [14] 93 0
Ethics approval number [14] 93 0
Ethics committee name [15] 94 0
St Vincent's Hospital, Melbourne
Ethics committee address [15] 94 0
Ethics committee country [15] 94 0
Australia
Date submitted for ethics approval [15] 94 0
Approval date [15] 94 0
Ethics approval number [15] 94 0
Ethics committee name [16] 95 0
Western Hospital
Ethics committee address [16] 95 0
Ethics committee country [16] 95 0
Australia
Date submitted for ethics approval [16] 95 0
Approval date [16] 95 0
Ethics approval number [16] 95 0
Ethics committee name [17] 96 0
Mount Hospital
Ethics committee address [17] 96 0
Ethics committee country [17] 96 0
Australia
Date submitted for ethics approval [17] 96 0
Approval date [17] 96 0
Ethics approval number [17] 96 0
Ethics committee name [18] 97 0
Sir Charles Gairdner Hospital
Ethics committee address [18] 97 0
Ethics committee country [18] 97 0
Australia
Date submitted for ethics approval [18] 97 0
Approval date [18] 97 0
Ethics approval number [18] 97 0
Ethics committee name [19] 98 0
Auckland Hospital
Ethics committee address [19] 98 0
Ethics committee country [19] 98 0
New Zealand
Date submitted for ethics approval [19] 98 0
Approval date [19] 98 0
Ethics approval number [19] 98 0
Ethics committee name [20] 99 0
Waikato Hospital
Ethics committee address [20] 99 0
Ethics committee country [20] 99 0
New Zealand
Date submitted for ethics approval [20] 99 0
Approval date [20] 99 0
Ethics approval number [20] 99 0

Summary
Brief summary
This randomised clinical trial will compare the combination of three cycles of chemotherapy (CMF) followed by tamoxifen versus tamoxifen alone in postmenopausal patients with node negative, oestrogen receptor positive breast cancer to determine which therapeutic strategy is better in terms of disease-free survival, overall survival and quality of life.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 35271 0
Prof John F Forbes
Address 35271 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35271 0
Australia
Phone 35271 0
+61 2 4985 0113
Fax 35271 0
Email 35271 0
enquiries@anzbctg.org
Contact person for public queries
Name 10472 0
John F Forbes
Address 10472 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10472 0
Australia
Phone 10472 0
+61 2 4925 3068
Fax 10472 0
+61 2 4985 0141
Email 10472 0
enquiries@anzbctg.org
Contact person for scientific queries
Name 1400 0
John F Forbes
Address 1400 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1400 0
Australia
Phone 1400 0
+ 61 2 4985 0113
Fax 1400 0
+ 61 2 4960 1539
Email 1400 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

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.