Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000034437
Ethics application status
Approved
Date submitted
27/05/1994
Date registered
27/05/1994
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
IBCSG 14-93 - Adjuvant therapy for post/peri menopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone
Scientific title
Adjuvant therapy for post/peri menopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone
Secondary ID [1] 1 0
National Clinical Trials Registry: NCTR62
Universal Trial Number (UTN)
Trial acronym
IBCSG 14-93
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 1 0
Condition category
Condition code
Cancer 1 1 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) followed by treatment with Tamoxifen (orally 20mg daily) for up to 5 years from randomisation.

Arm B: 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 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 (orally 20mg daily) for up to 5 years from randomisation

Arm C: 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) Followed by treatment with Toremifene (60mg orally daily) for up to 5 years from randomisation.

Arm D: 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 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 Toremifene (60mg orally daily) for up to 5 years from randomisation
Intervention code [1] 1281 0
Treatment: Drugs
Comparator / control treatment
Please see "Description of interventions" above.
Control group
Active

Outcomes
Primary outcome [1] 1 0
Disease Free Survival
Timepoint [1] 1 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] 1 0
Overall survival
Timepoint [1] 1 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] 2 0
Systemic Disease Free Survival
Timepoint [2] 2 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] 3 0
Sites of Relapse
Timepoint [3] 3 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] 4 0
Treatment Related Side Effects
Timepoint [4] 4 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 [5] 5 0
Quality of life
Timepoint [5] 5 0
Quality of life is measured 3 monthly during the first year, 6 monthly during year 2-5 and annually thereafter until year 6.

Eligibility
Key inclusion criteria
• Post/perimenopausal women 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
70 Years
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 or inflammatory breast cancer or with distant metastases• Bilateral malignancies, or with mass in opposite breast• Patients in whom the margins of the resected specimen contained tumour cells• Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or adequately treated in situ carcinoma of cervix• Patients who have received prior therapy for breast cancer including irradiation, chemotherapy or endocrine therapy• Patients with non-malignant systemic diseases preventing them from undergoing any of the treatment options or prolonged follow-up• Patients with psychiatric or addictive disorders preventing them from giving them informed consent• Bone scan 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 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
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
12/07/1993
Date of last participant enrolment
Anticipated
Actual
1/08/1999
Date of last data collection
Anticipated
Actual
Sample size
Target
760
Accrual to date
Final
969
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1 0
Canberra Hospital
Ethics committee address [1] 1 0
Ethics committee country [1] 1 0
Australia
Date submitted for ethics approval [1] 1 0
Approval date [1] 1 0
Ethics approval number [1] 1 0
Ethics committee name [2] 2 0
Dubbo Base Hospital
Ethics committee address [2] 2 0
Ethics committee country [2] 2 0
Australia
Date submitted for ethics approval [2] 2 0
Approval date [2] 2 0
Ethics approval number [2] 2 0
Ethics committee name [3] 3 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [3] 3 0
Ethics committee country [3] 3 0
Australia
Date submitted for ethics approval [3] 3 0
Approval date [3] 3 0
Ethics approval number [3] 3 0
Ethics committee name [4] 4 0
Prince of Wales Hospital
Ethics committee address [4] 4 0
Ethics committee country [4] 4 0
Australia
Date submitted for ethics approval [4] 4 0
Approval date [4] 4 0
Ethics approval number [4] 4 0
Ethics committee name [5] 5 0
Royal Prince Alfred Hospital
Ethics committee address [5] 5 0
Ethics committee country [5] 5 0
Australia
Date submitted for ethics approval [5] 5 0
Approval date [5] 5 0
01/05/1993
Ethics approval number [5] 5 0
Ethics committee name [6] 6 0
Flinders Medical Centre
Ethics committee address [6] 6 0
Ethics committee country [6] 6 0
Australia
Date submitted for ethics approval [6] 6 0
Approval date [6] 6 0
Ethics approval number [6] 6 0
Ethics committee name [7] 7 0
Albury Base Hospital
Ethics committee address [7] 7 0
Ethics committee country [7] 7 0
Australia
Date submitted for ethics approval [7] 7 0
Approval date [7] 7 0
Ethics approval number [7] 7 0
Ethics committee name [8] 8 0
Alfred Hospital
Ethics committee address [8] 8 0
Ethics committee country [8] 8 0
Australia
Date submitted for ethics approval [8] 8 0
Approval date [8] 8 0
Ethics approval number [8] 8 0
Ethics committee name [9] 9 0
Austin Health
Ethics committee address [9] 9 0
Ethics committee country [9] 9 0
Australia
Date submitted for ethics approval [9] 9 0
Approval date [9] 9 0
Ethics approval number [9] 9 0
Ethics committee name [10] 10 0
Bendigo Hospital
Ethics committee address [10] 10 0
Ethics committee country [10] 10 0
Australia
Date submitted for ethics approval [10] 10 0
Approval date [10] 10 0
Ethics approval number [10] 10 0
Ethics committee name [11] 11 0
Box Hill Hospital
Ethics committee address [11] 11 0
Ethics committee country [11] 11 0
Australia
Date submitted for ethics approval [11] 11 0
Approval date [11] 11 0
Ethics approval number [11] 11 0
Ethics committee name [12] 12 0
Geelong Hospital
Ethics committee address [12] 12 0
Ethics committee country [12] 12 0
Australia
Date submitted for ethics approval [12] 12 0
Approval date [12] 12 0
Ethics approval number [12] 12 0
Ethics committee name [13] 13 0
Maroondah Hospital
Ethics committee address [13] 13 0
Ethics committee country [13] 13 0
Australia
Date submitted for ethics approval [13] 13 0
Approval date [13] 13 0
Ethics approval number [13] 13 0
Ethics committee name [14] 14 0
Monash Medical Centre
Ethics committee address [14] 14 0
Ethics committee country [14] 14 0
Australia
Date submitted for ethics approval [14] 14 0
Approval date [14] 14 0
Ethics approval number [14] 14 0
Ethics committee name [15] 15 0
Peter MacCallum Cancer Centre
Ethics committee address [15] 15 0
Ethics committee country [15] 15 0
Australia
Date submitted for ethics approval [15] 15 0
Approval date [15] 15 0
Ethics approval number [15] 15 0
Ethics committee name [16] 16 0
Royal Melbourne Hospital
Ethics committee address [16] 16 0
Ethics committee country [16] 16 0
Australia
Date submitted for ethics approval [16] 16 0
Approval date [16] 16 0
Ethics approval number [16] 16 0
Ethics committee name [17] 17 0
St Vincent's Hospital, Melbourne
Ethics committee address [17] 17 0
Ethics committee country [17] 17 0
Australia
Date submitted for ethics approval [17] 17 0
Approval date [17] 17 0
Ethics approval number [17] 17 0
Ethics committee name [18] 18 0
Western Hospital
Ethics committee address [18] 18 0
Ethics committee country [18] 18 0
Australia
Date submitted for ethics approval [18] 18 0
Approval date [18] 18 0
Ethics approval number [18] 18 0
Ethics committee name [19] 19 0
Fremantle Hospital
Ethics committee address [19] 19 0
Ethics committee country [19] 19 0
Australia
Date submitted for ethics approval [19] 19 0
Approval date [19] 19 0
Ethics approval number [19] 19 0
Ethics committee name [20] 20 0
Mount Hospital
Ethics committee address [20] 20 0
Ethics committee country [20] 20 0
Australia
Date submitted for ethics approval [20] 20 0
Approval date [20] 20 0
Ethics approval number [20] 20 0
Ethics committee name [21] 21 0
Royal Perth Hospital
Ethics committee address [21] 21 0
Ethics committee country [21] 21 0
Australia
Date submitted for ethics approval [21] 21 0
Approval date [21] 21 0
Ethics approval number [21] 21 0

Summary
Brief summary
This clinical trial is for post and perimenopausal women who after their breast cancer surgery are found to have breast cancer which does not contain hormone receptors (is not stimulated by hormones), 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 as well as long term hormonal treatment for their breast cancer.

The optimal chemotherapy program involves two short courses of different
chemotherapy programmes (AC & CMF). 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 will be allocated by a process
called randomisation which is similar to tossing a coin. This clinical trial will assess
which method of giving chemotherapy is optimal for decreasing the chance of breast
cancer recurrence and increasing patient survival.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 35823 0
Prof John F Forbes
Address 35823 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 35823 0
Australia
Phone 35823 0
+61 2 4985 0113
Fax 35823 0
Email 35823 0
[email protected]
Contact person for public queries
Name 10470 0
Prof John F Forbes
Address 10470 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 10470 0
Australia
Phone 10470 0
+61 2 4925 3068
Fax 10470 0
+61 2 4985 0141
Email 10470 0
[email protected]
Contact person for scientific queries
Name 1398 0
Prof John F Forbes
Address 1398 0
ANZBCTG
PO Box 283
The Junction NSW 2291
Country 1398 0
Australia
Phone 1398 0
+ 61 2 4985 0113
Fax 1398 0
+ 61 2 4960 1539
Email 1398 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.