Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000532505
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 12-93 - Adjuvant therapy for post/perimenopausal patients with node positive breast cancer who have oestrogen receptor positive tumours
Scientific title
Adjuvant therapy for post/perimenopausal patients with node positive breast cancer who have oestrogen receptor positive tumours
Secondary ID [1] 5 0
National Clinical Trials Registry: NCTR18
Universal Trial Number (UTN)
Trial acronym
IBCSG 12-93
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 4 0
Condition category
Condition code
Cancer 4 4 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised in equal proportions to the following treatment arms:
*Chemotherapy (4 cycles) + concurrent then subsequent Tamoxifen (20mg orally daily) for 5 years from randomisation
* Chemotherapy (4 cycles) + subsequent Tamoxifen (20mg orally daily) for 5 years from randomisation
* Tamoxifen (20mg orally daily) alone for 5 years
* Chemotherapy (4 cycles) + concurrent then subsequent Toremifene (60mg orally daily) for 5 years from randomisation
* Chemotherapy (4 cycles) + subsequent Toremifene (60mg orally daily) for 5 years from randomisation
* Toremifene (60mg orally daily) alone for 5 years

Chemotherapy:
Doxorubicin 60mg/m2 (iv) and cyclophosphamide 600mg/m2 (iv) on day 1 of 21 day cycle
OR
Epirubicin 90mg/m2 (iv) and cyclophosphamide 600mg/m2 (iv) on day 1 of 21 day cycle
Intervention code [1] 1277 0
Treatment: Drugs
Comparator / control treatment
See Description of interventions above
Control group
Active

Outcomes
Primary outcome [1] 9 0
Overall survival
Timepoint [1] 9 0
Followed 12 monthly from randomisation until death.
Primary outcome [2] 10 0
Disease-free and systemic disease-free survival
Timepoint [2] 10 0
Followed every 12 months from randomisation until recurrence or death from any cause.
Secondary outcome [1] 14 0
Quality of life
Timepoint [1] 14 0
Assessed 3 monthly in year 1, 6 monthly in year 2 and then annually thereafter until year 6 from randomisation.
Secondary outcome [2] 15 0
Toxicity
Timepoint [2] 15 0
Assessed at the conclusion of each cycle of chemotherapy treatment and up until 30 days after the last dose date.

Eligibility
Key inclusion criteria
Post/perimenopausal women - Patients with positive lymph nodes (metastases detected in one or more of at least 8 ipsilateral axillary nodes examined)- Patients must be judged suitable for treatment with endocrine therapy alone. As a minimum, patients must have estrogen receptor positive tumours. (ER >= 10 fmol/mg cytosol protein or judged to be ER positive by immunohistochemical evaluation)- Patients must have had:a) Either total mastectomy or, optionally if the tumour was <= 5cm, a breast-conserving procedure (lumpectomy or quadrantectomy) b) Axillary clearance (not sampling) with at least eight lymph nodes available for pathological examinationc) The primary breast cancer surgical procedure within six weeks prior to randomisation- Minimum of eight lymph nodes histopathologically examined with at least one found positive- Tumour confined to the breast with no detected metastases - Adequate bone marrow function (WBC >= 4.0 x 10^9/L and platelets >+ 100 x 10^9/L)- Documented evidence of adequate renal function (creatinine < 120umol/L) and hepatic function (bilirubin <20umol/L, AST (SGOT) < 60 i.u./L)- Informed consent - Geographically accessible for follow-up
Minimum age
Not stated
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients without axillary node involvement- Malignant breast tumours other than carcinoma- T4 carcinoma with ulceration, infiltration of the skin, peau d'orange or inflammatory breast cancer, or with distant metastases- Bilateral malignancies, or mass in opposite breast- Margins of resected specimen contained tumour cells- Estrogen-receptor negative tumours- Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or in situ carcinoma of cervix- Prior therapy for breast cancer- Other non-malignant systemic disease preventing treatment options or follow-up- Psychiatric or addictive disorders preventing informed consent- Bone scans showing hot spots 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 Randomization by Telephone
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
1/05/1993
Actual
10/11/1993
Date of last participant enrolment
Anticipated
Actual
1/02/1997
Date of last data collection
Anticipated
Actual
Sample size
Target
960
Accrual to date
Final
452
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5 0
Self funded/Unfunded
Name [1] 5 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 5 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] 4 0
Other Collaborative groups
Name [1] 4 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 4 0
PO BOX 155
HRMC NSW 2310
Country [1] 4 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 36 0
Dubbo Base Hospital
Ethics committee address [1] 36 0
Ethics committee country [1] 36 0
Australia
Date submitted for ethics approval [1] 36 0
Approval date [1] 36 0
Ethics approval number [1] 36 0
Ethics committee name [2] 37 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [2] 37 0
Ethics committee country [2] 37 0
Australia
Date submitted for ethics approval [2] 37 0
Approval date [2] 37 0
Ethics approval number [2] 37 0
Ethics committee name [3] 38 0
Prince of Wales Hospital
Ethics committee address [3] 38 0
Ethics committee country [3] 38 0
Australia
Date submitted for ethics approval [3] 38 0
Approval date [3] 38 0
Ethics approval number [3] 38 0
Ethics committee name [4] 39 0
Royal Prince Alfred Hospital
Ethics committee address [4] 39 0
Ethics committee country [4] 39 0
Australia
Date submitted for ethics approval [4] 39 0
Approval date [4] 39 0
Ethics approval number [4] 39 0
Ethics committee name [5] 40 0
Flinders Medical Centre
Ethics committee address [5] 40 0
Ethics committee country [5] 40 0
Australia
Date submitted for ethics approval [5] 40 0
Approval date [5] 40 0
Ethics approval number [5] 40 0
Ethics committee name [6] 41 0
Austin Health
Ethics committee address [6] 41 0
Ethics committee country [6] 41 0
Australia
Date submitted for ethics approval [6] 41 0
Approval date [6] 41 0
Ethics approval number [6] 41 0
Ethics committee name [7] 42 0
Bendigo Hospital
Ethics committee address [7] 42 0
Ethics committee country [7] 42 0
Australia
Date submitted for ethics approval [7] 42 0
Approval date [7] 42 0
Ethics approval number [7] 42 0
Ethics committee name [8] 43 0
Box Hill Hospital
Ethics committee address [8] 43 0
Ethics committee country [8] 43 0
Australia
Date submitted for ethics approval [8] 43 0
Approval date [8] 43 0
Ethics approval number [8] 43 0
Ethics committee name [9] 44 0
Geelong Hospital
Ethics committee address [9] 44 0
Ethics committee country [9] 44 0
Australia
Date submitted for ethics approval [9] 44 0
Approval date [9] 44 0
01/05/1993
Ethics approval number [9] 44 0
Ethics committee name [10] 45 0
Royal Melbourne Hospital
Ethics committee address [10] 45 0
Ethics committee country [10] 45 0
Australia
Date submitted for ethics approval [10] 45 0
Approval date [10] 45 0
Ethics approval number [10] 45 0
Ethics committee name [11] 46 0
St Vincent's Hospital, Melbourne
Ethics committee address [11] 46 0
Ethics committee country [11] 46 0
Australia
Date submitted for ethics approval [11] 46 0
Approval date [11] 46 0
Ethics approval number [11] 46 0
Ethics committee name [12] 47 0
Western Hospital
Ethics committee address [12] 47 0
Ethics committee country [12] 47 0
Australia
Date submitted for ethics approval [12] 47 0
Approval date [12] 47 0
Ethics approval number [12] 47 0
Ethics committee name [13] 48 0
Royal Perth Hospital
Ethics committee address [13] 48 0
Ethics committee country [13] 48 0
Australia
Date submitted for ethics approval [13] 48 0
Approval date [13] 48 0
Ethics approval number [13] 48 0
Ethics committee name [14] 49 0
Sir Charles Gairdner Hospital
Ethics committee address [14] 49 0
Ethics committee country [14] 49 0
Australia
Date submitted for ethics approval [14] 49 0
Approval date [14] 49 0
Ethics approval number [14] 49 0

Summary
Brief summary
This clinical trial is for post and perimenopausal women who after having surgery for their breast cancer are found to have tumours which are stimulated by oestrogens (‘oestrogen receptor positive’) and who have cancer present in the glands of the arm pits (‘positive axillary lymph nodes’). For this group of women it is not known whether the addition of chemotherapy to hormonal treatment is beneficial in reducing disease recurrence and improving survival.

Patients on this trial will all receive a hormonal therapy for their breast cancer. Some patients will also receive chemotherapy either at the same time, or before their hormonal treatment. This will be determined by a process called randomisation which is similar to the toss of a coin. This trial assesses the optimal way of combining these treatments for this type of breast cancer.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 35892 0
Prof John F Forbes
Address 35892 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35892 0
Australia
Phone 35892 0
+61 2 4985 0113
Fax 35892 0
Email 35892 0
[email protected]
Contact person for public queries
Name 10466 0
Ms Corinna Beckmore
Address 10466 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10466 0
Australia
Phone 10466 0
+61 2 4925 3068
Fax 10466 0
+61 2 4985 0141
Email 10466 0
[email protected]
Contact person for scientific queries
Name 1394 0
Prof John F Forbes
Address 1394 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1394 0
Australia
Phone 1394 0
+ 61 2 4985 0113
Fax 1394 0
+ 61 2 4960 1539
Email 1394 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
No additional documents have been identified.