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Trial registered on ANZCTR


Registration number
ACTRN12607000035426
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 13-93 - Adjuvant therapy for premenopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone
Scientific title
Adjuvant therapy for premenopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone
Secondary ID [1] 9 0
National Clinical Trials Registry: NCTR94
Universal Trial Number (UTN)
Trial acronym
IBCSG Trial 13-93
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 9 0
Condition category
Condition code
Cancer 9 9 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: 4 cycles of Doxorubicin (60mg/m^2 iv) or Epirubicin (90mg/m^2 iv) and cyclophosphamide (600mg/m^2 iv) on day 1 of a 21 day cycle, followed by 3 cycles (1 cycle = 28 days) of Cyclophosphamide (100 mg/m^2 orally administered on Days 1-14), Methotrexate (40mg/m^2 iv on days 1 & 8) and 5-fluorouracil (600mg/m^2 iv on days 1 & 8)

Arm B: cycles of Doxorubicin (60mg/m^2 iv) or Epirubicin (90mg/m^2 iv) and cyclophosphamide (600mg/m^2 iv) ond day 1 of a 21 day cycle, followed by a 16 week gap prior to commencing 3 cycles (1 cycle = 28 days) of Cyclophosphamide (100 mg/m^2 orally administered on Days 1-14), Methotrexate (40mg/m^2 iv on days 1 & 8) and 5-fluorouracil (600mg/m^2 iv on days 1 & 8)

Arm C: cycles of Doxorubicin (60mg/m^2 iv) or Epirubicin (90mg/m^2 iv) and cyclophosphamide (600mg/m^2 iv) on day 1 of a 21 day cycle, followed by 3 cycles (1 cycle = 28 days) of Cyclophosphamide (100 mg/m^2 iv administer on Days 1-14), Methotrexate (40mg/m^2 iv on days 1 & 8) and 5-fluorouracil (600mg/m^2 iv on days 1 & 8). Followed by treatment with Tamoxifen (20mg orally daily) for up to 5 years from randomisation.

Arm D: cycles of Doxorubicin (60mg/m^2 iv) or Epirubicin (90mg/m^2 iv) and cyclophosphamide (600mg/m^2 iv) on day 1 of a 21 day cycle, followed by a 16 week gap prior to commencing 3 cycles (1 cycle = 28 days) of Cyclophosphamide (100 mg/m^2 orally administered on Days 1-14), Methotrexate (40mg/m^2 iv on days 1 & 8) and 5-fluorouracil (600mg/m^2 iv on days 1 & 8). Followed by treatment with Tamoxifen (20mg orally daily) for up to 5 years from randomisation
Intervention code [1] 1284 0
Treatment: Drugs
Comparator / control treatment
See "Description of Intervention" above. Please note that this trial closed to recruitment in 1999 and is now completed.
Control group
Active

Outcomes
Primary outcome [1] 15 0
Disease free survival
Timepoint [1] 15 0
Patients are assessed by clinicians for progression of disease 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.
Secondary outcome [1] 27 0
Overall survival
Timepoint [1] 27 0
Patients are assessed by clinicians for the secondary endpoints 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.
Secondary outcome [2] 28 0
Sites of relapse
Timepoint [2] 28 0
Patients are assessed by clinicians for the secondary endpoints 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.
Secondary outcome [3] 29 0
Treatment related side effects
Timepoint [3] 29 0
Patients are assessed by clinicians for the secondary endpoints 3 monthly during years 1 – 2, 6 monthly during years 3-5 and then annually until death.
Secondary outcome [4] 30 0
Quality of life
Timepoint [4] 30 0
Measured 3 monthly during the first year, 6 monthly during year 2 and annually thereafter until year 6.

Eligibility
Key inclusion criteria
• Premenopausal women (aged 18 or over) with histologically proven primary breast cancer• Positive lymph nodes (metastases detected in one or more of at least 8 ipsilateral axillary nodes examined). Primary tumour must be classified as T1a,b,c ,T2 or T3, pN1, M0.• Patients must be judged not suitable for treatment with endocrine therapy alone. Estrogen receptor status must be known before randomisation• Patients must have had:a) Either total mastectomy or breast conserving procedureb) Axillary clearance with at least 8 lymph nodes available for pathological examinationc) Primary breast cancer surgical procedure must be within 6 weeks prior to randomisation• Tumour must be confined to breast without detected metastases other than those within lymph nodes• Adequate marrow function (WBC > 4.0 x 10^9/l and platelet count > 100 x 10^9/l)• Adequate renal function (serum creatinine < 120umol/l) and hepatic function (serum bilirubin < 20 umol/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 tumours other than carcinoma• T4 carcinoma with ulceration of skin, infiltration of skin, peau d'orange of inflammatory breast cancer, or with distant metastases.• Bilateral malignancies, or mass in opposite breast, unless mass has been proven by biopsy to be benign• Patients in whom margins of resected specimen contained tumour cells• Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or in situ carcinoma of cervix• Prior therapy for breast cancer including prior radiation, chemotherapy or endocrine therapy• Non-malignant systemic diseases preventing treatment options or follow-up• Psychiatric or addictive disorders preventing informed consent• Bone scan showing hot spots which cannot be confirmed as benign disease• Pregnant or lactating women

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 or 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
1/05/1993
Actual
28/06/1993
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
1294
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 10 0
Self funded/Unfunded
Name [1] 10 0
Australia and New Zealand Breast Cancer Trials Group
Country [1] 10 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] 9 0
Other Collaborative groups
Name [1] 9 0
Australia and New Zealand Breast Cancer Trials Group
Address [1] 9 0
PO BOX 155
HRMC NSW 2310
Country [1] 9 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 100 0
Dubbo Base Hospital
Ethics committee address [1] 100 0
Ethics committee country [1] 100 0
Australia
Date submitted for ethics approval [1] 100 0
Approval date [1] 100 0
Ethics approval number [1] 100 0
Ethics committee name [2] 101 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [2] 101 0
Ethics committee country [2] 101 0
Australia
Date submitted for ethics approval [2] 101 0
Approval date [2] 101 0
Ethics approval number [2] 101 0
Ethics committee name [3] 102 0
Prince of Wales Hospital
Ethics committee address [3] 102 0
Ethics committee country [3] 102 0
Australia
Date submitted for ethics approval [3] 102 0
Approval date [3] 102 0
Ethics approval number [3] 102 0
Ethics committee name [4] 103 0
Royal Prince Alfred Hospital
Ethics committee address [4] 103 0
Ethics committee country [4] 103 0
Australia
Date submitted for ethics approval [4] 103 0
Approval date [4] 103 0
01/05/1993
Ethics approval number [4] 103 0
Ethics committee name [5] 104 0
St George Hospital
Ethics committee address [5] 104 0
Ethics committee country [5] 104 0
Australia
Date submitted for ethics approval [5] 104 0
Approval date [5] 104 0
Ethics approval number [5] 104 0
Ethics committee name [6] 105 0
Flinders Medical Centre
Ethics committee address [6] 105 0
Ethics committee country [6] 105 0
Australia
Date submitted for ethics approval [6] 105 0
Approval date [6] 105 0
Ethics approval number [6] 105 0
Ethics committee name [7] 106 0
Albury Base Hospital
Ethics committee address [7] 106 0
Ethics committee country [7] 106 0
Australia
Date submitted for ethics approval [7] 106 0
Approval date [7] 106 0
Ethics approval number [7] 106 0
Ethics committee name [8] 107 0
Alfred Hospital
Ethics committee address [8] 107 0
Ethics committee country [8] 107 0
Australia
Date submitted for ethics approval [8] 107 0
Approval date [8] 107 0
Ethics approval number [8] 107 0
Ethics committee name [9] 108 0
Austin Health
Ethics committee address [9] 108 0
Ethics committee country [9] 108 0
Australia
Date submitted for ethics approval [9] 108 0
Approval date [9] 108 0
Ethics approval number [9] 108 0
Ethics committee name [10] 109 0
Bendigo Hospital
Ethics committee address [10] 109 0
Ethics committee country [10] 109 0
Australia
Date submitted for ethics approval [10] 109 0
Approval date [10] 109 0
Ethics approval number [10] 109 0
Ethics committee name [11] 110 0
Box Hill Hospital
Ethics committee address [11] 110 0
Ethics committee country [11] 110 0
Australia
Date submitted for ethics approval [11] 110 0
Approval date [11] 110 0
Ethics approval number [11] 110 0
Ethics committee name [12] 111 0
Geelong Hospital
Ethics committee address [12] 111 0
Ethics committee country [12] 111 0
Australia
Date submitted for ethics approval [12] 111 0
Approval date [12] 111 0
Ethics approval number [12] 111 0
Ethics committee name [13] 112 0
Maroondah Hospital
Ethics committee address [13] 112 0
Ethics committee country [13] 112 0
Australia
Date submitted for ethics approval [13] 112 0
Approval date [13] 112 0
Ethics approval number [13] 112 0
Ethics committee name [14] 113 0
Monash Medical Centre
Ethics committee address [14] 113 0
Ethics committee country [14] 113 0
Australia
Date submitted for ethics approval [14] 113 0
Approval date [14] 113 0
Ethics approval number [14] 113 0
Ethics committee name [15] 114 0
Peter MacCallum Cancer
Ethics committee address [15] 114 0
Ethics committee country [15] 114 0
Australia
Date submitted for ethics approval [15] 114 0
Approval date [15] 114 0
Ethics approval number [15] 114 0
Ethics committee name [16] 115 0
Royal Melbourne Hospital
Ethics committee address [16] 115 0
Ethics committee country [16] 115 0
Australia
Date submitted for ethics approval [16] 115 0
Approval date [16] 115 0
Ethics approval number [16] 115 0
Ethics committee name [17] 116 0
St Vincent's Hospital, Melbourne
Ethics committee address [17] 116 0
Ethics committee country [17] 116 0
Australia
Date submitted for ethics approval [17] 116 0
Approval date [17] 116 0
Ethics approval number [17] 116 0
Ethics committee name [18] 117 0
Western Hospital
Ethics committee address [18] 117 0
Ethics committee country [18] 117 0
Australia
Date submitted for ethics approval [18] 117 0
Approval date [18] 117 0
Ethics approval number [18] 117 0
Ethics committee name [19] 118 0
Mount Hospital
Ethics committee address [19] 118 0
Ethics committee country [19] 118 0
Australia
Date submitted for ethics approval [19] 118 0
Approval date [19] 118 0
Ethics approval number [19] 118 0
Ethics committee name [20] 119 0
Royal Perth Hospital
Ethics committee address [20] 119 0
Ethics committee country [20] 119 0
Australia
Date submitted for ethics approval [20] 119 0
Approval date [20] 119 0
Ethics approval number [20] 119 0
Ethics committee name [21] 120 0
Sir Charles Gairdner Hospital
Ethics committee address [21] 120 0
Ethics committee country [21] 120 0
Australia
Date submitted for ethics approval [21] 120 0
Approval date [21] 120 0
Ethics approval number [21] 120 0
Ethics committee name [22] 121 0
Auckland Hospital
Ethics committee address [22] 121 0
Ethics committee country [22] 121 0
New Zealand
Date submitted for ethics approval [22] 121 0
Approval date [22] 121 0
Ethics approval number [22] 121 0

Summary
Brief summary
This clinical trial is for premenopausal women who after their breast cancer surgery
are found to have breast cancer which is not suitable for hormonal treatment alone,
and who also have cancer cells in the glands of the arm pit ('positive axillary lymph nodes’). It is known that these women will benefit substantially by having
chemotherapy after surgery for breast cancer.
The optimal chemotherapy program involves two short courses of different
chemotherapy programmes (AC [doxorubicin or epirubicin + cyclophosphamide] & CMF [cyclophosphamide, methotrexate, 5-fluorouracil). It is not known whether the second chemotherapy course (CMF) should begin immediately after the first course (AC) or whether it should be delayed with a break in between. Whether or not a patient will have a gap between her chemotherapy programmes, as well as whether she will have Tamoxifen or not will be allocated by a process called randomisation which is similar to tossing a coin.

This trial will test whether the delay between the chemotherapy courses is needed as well as if there is an extra benefit of adding a hormonal treatment to the chemotherapy.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 35502 0
Prof John F Forbes
Address 35502 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35502 0
Australia
Phone 35502 0
+61 2 4985 0113
Fax 35502 0
Email 35502 0
[email protected]
Contact person for public queries
Name 10473 0
John F Forbes
Address 10473 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10473 0
Australia
Phone 10473 0
+61 2 4925 3068
Fax 10473 0
+61 2 4985 0141
Email 10473 0
[email protected]
Contact person for scientific queries
Name 1401 0
John F Forbes
Address 1401 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1401 0
Australia
Phone 1401 0
+ 61 2 4985 0113
Fax 1401 0
+ 61 2 4960 1539
Email 1401 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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