Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000534583
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 11-93 - Adjuvant therapy for premenopausal patients with node positive breast cancer who are suitable for endocrine therapy alone
Scientific title
Adjuvant therapy for premenopausal patients with node positive breast cancer who are suitable for endocrine therapy alone
Secondary ID [1] 6 0
National Clinical Trials Registry: NCTR19
Universal Trial Number (UTN)
Trial acronym
IBCSG 11-93
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 5 0
Condition category
Condition code
Cancer 5 5 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Ovarian ablation and Tamoxifen (20mg orally daily) maintenance to 5 years
Arm B: Ovarian ablation + 4 cycles of Doxorubicin (60mg/m^2 iv) or epirubicin (90mg/m^2 iv) and cyclophosphamide (600mg/m^2 iv), followed by Tamoxifen (20mg orally daily) maintenance to 5 years.

Ovarian ablation can use any of the following methods:
* bilateral surgical oophorectomy via laparatomy or laparascopy OR
* bilateral ovarian irradiation OR
* GnRH (gonadotropin releasing hormone) analogue 3.6mg every 28 days continued for 2 years or until the patient is 55 years old, whichever is longer. Note: ovarian ablation initiated with GnRH analogue may be continued by oophorectomy or radiation therapy.
Chemotherapy (21 day cycles) should start immediately after the ovarian ablation procedure or at day 1 of GnRH(gonadotropin releasing hormone) analogue administration; within 6 weeks of primary surgery.
Intervention code [1] 1278 0
Treatment: Drugs
Comparator / control treatment
Please see "Description of interventions" above. Study completed recruitment in 1998.
Control group
Active

Outcomes
Primary outcome [1] 11 0
Overall survival
Timepoint [1] 11 0
Patients are followed at each chemotherapy cycle and 3 monthly in the first year, 6 monthly years 2-5 and yearly thereafter for life.
Primary outcome [2] 12 0
Disease-free and systemic disease-free survival
Timepoint [2] 12 0
Patients are followed at each chemotherapy cycle and 3 monthly in the first year, 6 monthly years 2-5 and yearly thereafter for life.
Secondary outcome [1] 16 0
Quality of life
Timepoint [1] 16 0
Assessed 3 monthly in the first year, 6 monthly in year 2 and annually thereafter to year 6.
Secondary outcome [2] 17 0
Toxicity
Timepoint [2] 17 0
Assessed at the conclusion of each cycle of treatment up to 30 days after the last dose date.

Eligibility
Key inclusion criteria
• Premenopausal women with histologically proven primary breast cancer• Positive lymph nodes (metastases detected in 1 or more of at least 8 ipsilateral axillary nodes examined). The primary tumour must be classified as T1a,b,c T2 or T3, pN1, M0 (UICC 1987)• Patients must be judged suitable for treatment with endocrine therapy alone. As a minimum, must have ER positive tumours (ER>= 10 fmol/mg cytosol protein) or PR positive tumours (PgR>= 10 fmol/my cytosol protein)• Patients must have had:a) Either total mastectomy or, optionally if the tumour is <=5cm, breast-conserving procedure (lumpectomy or quadrantectomy)b) Axillary clearance with at least eight lymph nodes available for pathological examinationc) The primary breast cancer surgical procedure must be within 6 weeks prior to randomisation• Minimum of 8 lymph nodes histopathologically examined with at least one found positive• Tumour must be confined to breast without detected metastases• Adequate marrow function (WBC >= 4.0 x 10^9/L and platelet count >= 100 x 10^9/L)• Adequate renal function (serum creatinine < 120 umol/L) and hepatic function (serum bilirubin < 20umol/L, AST (SGOT) < 60 i.u./L)• Informed consent• Geographically accessible for follow-up
Minimum age
18 Years
Maximum age
Not stated
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 skin, peau d'orange or inflammatory breast cancer• Bilateral malignancies, or mass in opposite breast• Margins of resected specimen contained tumour cells• ER- and PR- 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• Non-malignant systemic diseases 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• Pregnant or lactating

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 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
15/07/1993
Date of last participant enrolment
Anticipated
Actual
1/11/1998
Date of last data collection
Anticipated
Actual
Sample size
Target
760
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 6 0
Self funded/Unfunded
Name [1] 6 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 6 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] 5 0
Other Collaborative groups
Name [1] 5 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 5 0
PO BOX 155
HRMC NSW 2310
Country [1] 5 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 50 0
Dubbo Base Hospital
Ethics committee address [1] 50 0
Ethics committee country [1] 50 0
Australia
Date submitted for ethics approval [1] 50 0
Approval date [1] 50 0
Ethics approval number [1] 50 0
Ethics committee name [2] 51 0
Liverpool Hospital
Ethics committee address [2] 51 0
Ethics committee country [2] 51 0
Australia
Date submitted for ethics approval [2] 51 0
Approval date [2] 51 0
Ethics approval number [2] 51 0
Ethics committee name [3] 52 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [3] 52 0
Ethics committee country [3] 52 0
Australia
Date submitted for ethics approval [3] 52 0
Approval date [3] 52 0
Ethics approval number [3] 52 0
Ethics committee name [4] 53 0
Prince of Wales Hospital
Ethics committee address [4] 53 0
Ethics committee country [4] 53 0
Australia
Date submitted for ethics approval [4] 53 0
Approval date [4] 53 0
Ethics approval number [4] 53 0
Ethics committee name [5] 54 0
Royal Prince Alfred Hospital
Ethics committee address [5] 54 0
Ethics committee country [5] 54 0
Australia
Date submitted for ethics approval [5] 54 0
Approval date [5] 54 0
01/05/1993
Ethics approval number [5] 54 0
Ethics committee name [6] 55 0
Bendigo Hospital
Ethics committee address [6] 55 0
Ethics committee country [6] 55 0
Australia
Date submitted for ethics approval [6] 55 0
Approval date [6] 55 0
Ethics approval number [6] 55 0
Ethics committee name [7] 56 0
Geelong Hospital
Ethics committee address [7] 56 0
Ethics committee country [7] 56 0
Australia
Date submitted for ethics approval [7] 56 0
Approval date [7] 56 0
Ethics approval number [7] 56 0
Ethics committee name [8] 57 0
Royal Melbourne Hospital
Ethics committee address [8] 57 0
Ethics committee country [8] 57 0
Australia
Date submitted for ethics approval [8] 57 0
Approval date [8] 57 0
Ethics approval number [8] 57 0
Ethics committee name [9] 58 0
St Vincent's Hospital, Melbourne
Ethics committee address [9] 58 0
Ethics committee country [9] 58 0
Australia
Date submitted for ethics approval [9] 58 0
Approval date [9] 58 0
Ethics approval number [9] 58 0
Ethics committee name [10] 59 0
Western Hospital
Ethics committee address [10] 59 0
Ethics committee country [10] 59 0
Australia
Date submitted for ethics approval [10] 59 0
Approval date [10] 59 0
Ethics approval number [10] 59 0
Ethics committee name [11] 60 0
Sir Charles Gairdner Hospital
Ethics committee address [11] 60 0
Ethics committee country [11] 60 0
Australia
Date submitted for ethics approval [11] 60 0
Approval date [11] 60 0
Ethics approval number [11] 60 0
Ethics committee name [12] 61 0
Auckland Hospital
Ethics committee address [12] 61 0
Ethics committee country [12] 61 0
New Zealand
Date submitted for ethics approval [12] 61 0
Approval date [12] 61 0
Ethics approval number [12] 61 0
Ethics committee name [13] 62 0
Waikato Hospital
Ethics committee address [13] 62 0
Ethics committee country [13] 62 0
New Zealand
Date submitted for ethics approval [13] 62 0
Approval date [13] 62 0
Ethics approval number [13] 62 0

Summary
Brief summary
This trial involves premenopausal women who after surgery for their breast cancer are found to have tumours which are hormone receptor positive (stimulated by hormones) and who also have positive axillary lymph nodes (‘glands under the arm pit’ containing cancer). For these women it is not known whether hormonal treatment alone is sufficient, or whether the addition of chemotherapy may be beneficial in reducing the incidence of disease recurrence and improving survival.

Women who take part in this trial will all have their ovarian function suppressed and receive Tamoxifen. In addition, patients may or may not receive chemotherapy.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 36193 0
Prof John F Forbes
Address 36193 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 36193 0
Australia
Phone 36193 0
+61 2 4985 0113
Fax 36193 0
Email 36193 0
[email protected]
Contact person for public queries
Name 10467 0
Prof Corinna Beckmore
Address 10467 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10467 0
Australia
Phone 10467 0
+61 2 4925 3068
Fax 10467 0
+61 2 4985 0141
Email 10467 0
[email protected]
Contact person for scientific queries
Name 1395 0
Prof John F Forbes
Address 1395 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1395 0
Australia
Phone 1395 0
+ 61 2 4985 0113
Fax 1395 0
+ 61 2 4960 1539
Email 1395 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.