Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000012471
Ethics application status
Approved
Date submitted
17/12/2003
Date registered
17/12/2003
Date last updated
19/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adjuvant Therapy for Postmenopausal Patients with Operable Breast Cancer who have Estrogen Receptor or Progesterone Receptor Positive Tumors.
Tamoxifen vs. Letrozole vs. Tamoxifen followed by Letrozole vs. Letrozole followed by Tamoxifen
Scientific title
A phase III study to evaluate letrozole as adjuvant endocrine therapy for postmenopausal women with receptor (ER and/or PgR) positive tumours
Secondary ID [1] 37 0
National Clinical Trials Registry: NCTR447
Universal Trial Number (UTN)
Trial acronym
IBCSG 18-98 / BIG 1-98(Letrozole)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 39 0
Condition category
Condition code
Cancer 46 46 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomised to one of the following treatment arms:
Tamoxifen (20mg orally once a day) for 5 years
Vs
Letrozole (2.5mg orally once a day) for 5 years
Vs
Tamoxifen (20mg orally once a day) for 2 years, followed by letrozole (2.5mg orally once a day) for 3 years.
Vs
Letrozole (2.5mg orally once a day) for 2 years, followed by tamoxifen (20mg orally once a day) for 3 years.
Intervention code [1] 1243 0
Treatment: Drugs
Comparator / control treatment
to be confirmed
Control group
Active

Outcomes
Primary outcome [1] 75 0
The primary endpoint is disease free survival. Disease free-survival is defined as the time from randomisation to recurrence (including recurrence restricted to the breast after breast conserving treatment), metastasis, appearance of a second primary tumour, or death from any cause, whichever occurs first.
Timepoint [1] 75 0
Patients are assessed by clinicians for progression of disease and survival every 6 months until 5 years from randomisation and then annually thereafter for life.
Secondary outcome [1] 141 0
The secondary endpoint is overall survival and safety.
Timepoint [1] 141 0
Patients are assessed by clinicians for survival every 6 months for the first 5 years on study and annually thereafter for life.
Secondary outcome [2] 142 0
Patients are also assessed for tolerability of treatment and side effects
Timepoint [2] 142 0
Every 6 months during the first five years on study or until 30 days after treatment is completed.
Secondary outcome [3] 143 0
Accrual, toxicity and deaths will be monitored.
Timepoint [3] 143 0
to be confirmed

Eligibility
Key inclusion criteria
Compliant postmenopausal women with histologically proven breast cancer who have had either a total mastectomy or a lesser procedure who are classified as pT1-3 or pT4b, Nx, Nsentinel-ve, N0-2, M0, and have oestrogen receptor and/or progesterone receptor positive tumours (ER/PR=10 fmol/mg cytosol protein or =10% of tumour cells positive by immunocytochemical assay); judged suitable for endocrine treatment; adequate marrow function, adequate renal and hepatic function; written and dated informed consent; geographically accessible for follow up; informed of data and material transfer and handling.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with distant metastases. Bilateral breast cancer except in situ lesions of the contralateral breast. Patients with prior ipsilateral in situ breast cancer. Patients with previous history of concomitant other (not breast) malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous malignancy must have been disease free for five years. Patients receiving adjuvant chemotherapy at randomisation. Patients with other non-malignant systemic diseases. Patients treated with systemic investigational drugs within the past 30 days or topical investigational drugs within the past 7 days. History of non-compliance to medical regimens and patients who are considered potentially unreliable. Patients known to be HIV positive.

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)
The Australian New Zealand Breast Cancer Trials Group Statistical Centre at the National Health Medical Research Council Clinical Trials Centre, University of Sydney provided a central randomisation service by fax for all Australian and New Zealand institutions. At the time of study entry all participants were allocated a treatment arm via a web-based randomization system and treatment was supplied in accordance with the allocated drug kit code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, investigators (clinicians treating the patients) and pharmacists are blinded to the study treatment
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6193
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 65 0
Self funded/Unfunded
Name [1] 65 0
Australian New Zealand Breast Cancer Trials Group
Country [1] 65 0
Australia
Funding source category [2] 66 0
Commercial sector/Industry
Name [2] 66 0
Novartis Pharma AG, Basel
Country [2] 66 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharma AG, Basel
Address
to be confirmed
Country
Switzerland
Secondary sponsor category [1] 50 0
Other Collaborative groups
Name [1] 50 0
International Breast Cancer Study Group
Address [1] 50 0
As the trial is now complete. No further information will be added due to time constraints.
Country [1] 50 0
Australia
Secondary sponsor category [2] 51 0
Other Collaborative groups
Name [2] 51 0
Australian New Zealand Breast Cancer Trials Group
Address [2] 51 0
As the trial is now complete. No further information will be added due to time constraints.
Country [2] 51 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 402 0
Auckland Hospital
Ethics committee address [1] 402 0
Ethics committee country [1] 402 0
New Zealand
Date submitted for ethics approval [1] 402 0
Approval date [1] 402 0
Ethics approval number [1] 402 0
Ethics committee name [2] 403 0
Border Medical Oncology
Ethics committee address [2] 403 0
Ethics committee country [2] 403 0
Australia
Date submitted for ethics approval [2] 403 0
Approval date [2] 403 0
Ethics approval number [2] 403 0
Ethics committee name [3] 404 0
Box Hill Hospital
Ethics committee address [3] 404 0
Ethics committee country [3] 404 0
Australia
Date submitted for ethics approval [3] 404 0
Approval date [3] 404 0
Ethics approval number [3] 404 0
Ethics committee name [4] 405 0
Cabrini Hospital
Ethics committee address [4] 405 0
Ethics committee country [4] 405 0
Australia
Date submitted for ethics approval [4] 405 0
Approval date [4] 405 0
Ethics approval number [4] 405 0
Ethics committee name [5] 406 0
Christchurch Hospital
Ethics committee address [5] 406 0
Ethics committee country [5] 406 0
New Zealand
Date submitted for ethics approval [5] 406 0
Approval date [5] 406 0
Ethics approval number [5] 406 0
Ethics committee name [6] 407 0
Dunedin Hospital
Ethics committee address [6] 407 0
Ethics committee country [6] 407 0
New Zealand
Date submitted for ethics approval [6] 407 0
Approval date [6] 407 0
Ethics approval number [6] 407 0
Ethics committee name [7] 408 0
Frankston Hospital
Ethics committee address [7] 408 0
Ethics committee country [7] 408 0
Australia
Date submitted for ethics approval [7] 408 0
Approval date [7] 408 0
Ethics approval number [7] 408 0
Ethics committee name [8] 409 0
Geelong Hospital
Ethics committee address [8] 409 0
Ethics committee country [8] 409 0
Australia
Date submitted for ethics approval [8] 409 0
Approval date [8] 409 0
Ethics approval number [8] 409 0
Ethics committee name [9] 410 0
Launceston General Hospital
Ethics committee address [9] 410 0
Ethics committee country [9] 410 0
Australia
Date submitted for ethics approval [9] 410 0
Approval date [9] 410 0
Ethics approval number [9] 410 0
Ethics committee name [10] 411 0
Liverpool Hospital
Ethics committee address [10] 411 0
Ethics committee country [10] 411 0
Australia
Date submitted for ethics approval [10] 411 0
Approval date [10] 411 0
Ethics approval number [10] 411 0
Ethics committee name [11] 412 0
Maroondah Hospital
Ethics committee address [11] 412 0
Ethics committee country [11] 412 0
Australia
Date submitted for ethics approval [11] 412 0
Approval date [11] 412 0
Ethics approval number [11] 412 0
Ethics committee name [12] 413 0
Monash Medical Centre
Ethics committee address [12] 413 0
Ethics committee country [12] 413 0
Australia
Date submitted for ethics approval [12] 413 0
Approval date [12] 413 0
Ethics approval number [12] 413 0
Ethics committee name [13] 414 0
Mount Hospital
Ethics committee address [13] 414 0
Ethics committee country [13] 414 0
Australia
Date submitted for ethics approval [13] 414 0
Approval date [13] 414 0
Ethics approval number [13] 414 0
Ethics committee name [14] 415 0
Nepean Cancer Care Centre
Ethics committee address [14] 415 0
Ethics committee country [14] 415 0
Australia
Date submitted for ethics approval [14] 415 0
Approval date [14] 415 0
Ethics approval number [14] 415 0
Ethics committee name [15] 416 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [15] 416 0
Ethics committee country [15] 416 0
Australia
Date submitted for ethics approval [15] 416 0
Approval date [15] 416 0
Ethics approval number [15] 416 0
Ethics committee name [16] 417 0
Peter MacCallum Cancer Centre
Ethics committee address [16] 417 0
Ethics committee country [16] 417 0
Australia
Date submitted for ethics approval [16] 417 0
Approval date [16] 417 0
Ethics approval number [16] 417 0
Ethics committee name [17] 418 0
Prince of Wales Hospital
Ethics committee address [17] 418 0
Ethics committee country [17] 418 0
Australia
Date submitted for ethics approval [17] 418 0
Approval date [17] 418 0
Ethics approval number [17] 418 0
Ethics committee name [18] 419 0
Princess Alexandra Hospital
Ethics committee address [18] 419 0
Ethics committee country [18] 419 0
Australia
Date submitted for ethics approval [18] 419 0
Approval date [18] 419 0
Ethics approval number [18] 419 0
Ethics committee name [19] 420 0
Royal Adelaide Hospital
Ethics committee address [19] 420 0
Ethics committee country [19] 420 0
Australia
Date submitted for ethics approval [19] 420 0
Approval date [19] 420 0
Ethics approval number [19] 420 0
Ethics committee name [20] 421 0
Royal Brisbane and Women's Hospital
Ethics committee address [20] 421 0
Ethics committee country [20] 421 0
Australia
Date submitted for ethics approval [20] 421 0
Approval date [20] 421 0
Ethics approval number [20] 421 0
Ethics committee name [21] 422 0
Royal Hobart Hospital
Ethics committee address [21] 422 0
Ethics committee country [21] 422 0
Australia
Date submitted for ethics approval [21] 422 0
Approval date [21] 422 0
Ethics approval number [21] 422 0
Ethics committee name [22] 423 0
Royal Melbourne Hospital
Ethics committee address [22] 423 0
Ethics committee country [22] 423 0
Australia
Date submitted for ethics approval [22] 423 0
Approval date [22] 423 0
Ethics approval number [22] 423 0
Ethics committee name [23] 424 0
Royal Perth Hospital
Ethics committee address [23] 424 0
Ethics committee country [23] 424 0
Australia
Date submitted for ethics approval [23] 424 0
Approval date [23] 424 0
Ethics approval number [23] 424 0
Ethics committee name [24] 425 0
Sir Charles Gairdner Hospital
Ethics committee address [24] 425 0
Ethics committee country [24] 425 0
Australia
Date submitted for ethics approval [24] 425 0
Approval date [24] 425 0
Ethics approval number [24] 425 0
Ethics committee name [25] 426 0
St Vincent's Hospital, Melbourne
Ethics committee address [25] 426 0
Ethics committee country [25] 426 0
Australia
Date submitted for ethics approval [25] 426 0
Approval date [25] 426 0
Ethics approval number [25] 426 0
Ethics committee name [26] 427 0
Toowoomba Base Hospital
Ethics committee address [26] 427 0
Ethics committee country [26] 427 0
Australia
Date submitted for ethics approval [26] 427 0
Approval date [26] 427 0
Ethics approval number [26] 427 0
Ethics committee name [27] 428 0
Waikato Hospital
Ethics committee address [27] 428 0
Ethics committee country [27] 428 0
New Zealand
Date submitted for ethics approval [27] 428 0
Approval date [27] 428 0
Ethics approval number [27] 428 0
Ethics committee name [28] 429 0
Western Hospital
Ethics committee address [28] 429 0
Ethics committee country [28] 429 0
Australia
Date submitted for ethics approval [28] 429 0
Approval date [28] 429 0
Ethics approval number [28] 429 0
Ethics committee name [29] 430 0
Westmead Hospital
Ethics committee address [29] 430 0
Ethics committee country [29] 430 0
Australia
Date submitted for ethics approval [29] 430 0
Approval date [29] 430 0
Ethics approval number [29] 430 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36249 0
Address 36249 0
Country 36249 0
Phone 36249 0
Fax 36249 0
Email 36249 0
Contact person for public queries
Name 10432 0
Administrative Officer, Data Management
Address 10432 0
Australian New Zealand Breast Cancer Trials Group Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 10432 0
Australia
Phone 10432 0
+61 2 4925 3068
Fax 10432 0
+61 2 49850141
Email 10432 0
[email protected]
Contact person for scientific queries
Name 1360 0
Professor John F Forbes
Address 1360 0
Australian New Zealand Breast Cancer Trials Group Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 1360 0
Australia
Phone 1360 0
+61 2 4985 0113
Fax 1360 0
+ 61 2 4960 1539
Email 1360 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.