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Trial registered on ANZCTR


Registration number
ACTRN12606000499583
Ethics application status
Approved
Date submitted
3/11/1994
Date registered
3/11/1994
Date last updated
24/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
ANZ 8811: A Phase III study to compare the effect of Zoladex depot (ICI 118,630) with Nolvadex plus Zoladex depot in pre- and peri-menopausal patients with advanced breast cancer.
Scientific title
ANZ 8811: A Phase III study to compare the effect of Zoladex depot (ICI 118, 630) with Nolvadex plus Zoladex depot in pre- and peri-menopausal patients with advanced breast cancer.
Secondary ID [1] 10 0
National Clinical Trials Registry: NCTR96
Universal Trial Number (UTN)
Trial acronym
ANZ 8811
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced breast cancer 3 0
Condition category
Condition code
Cancer 3 3 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B: Zoladex plus Nolvadex
Nolvadex (in Arm B and only after on-treatment progression in Arm A) is administered orally, in tablet form, at a dose of 40 mg (ie two tablets) once daily.
Patients will receive study therapy until one of the following treatment endpoints is reached:
a) Severe adverse reaction,
b) Patient unwilling/unable to continue therapy,
c) Objective progression of breast cancer,
d) Death,
e) Study inclusion/exclusion criteria are violated at any time,
f) Patient receives systemic treatment for breast cancer or receives non-protocol treatment, known to effect hormonal status.
All patients will be followed up until the last patient has been followed up for at least 1 year, or has withdrawn from the study (whichever occurs first).
Intervention code [1] 1286 0
Treatment: Drugs
Comparator / control treatment
Arm A: Zoladex only (with Nolvadex added at progression on treatment)
Zoladex is administered (in Arm A and Arm B) as a 3.6 mg depot injected subcutaneously every 28 days.
Patients randomised to receive 'Zoladex only' will receive Nolvadex (in addition to Zoladex) at first objective progression and will continue therapy until a second endpoint is reached.
All patients will be followed up until the last patient has been followed up for at least 1 year, or has withdrawn from the study (whichever occurs first).
Control group
Active

Outcomes
Primary outcome [1] 16 0
To compare the two treatment arms in terms of best response.
Timepoint [1] 16 0
The outcome will be determined via subjective assessments (reported symptoms), objective assessment (ie palpation and measurement, isotope bone scan, x-ray, skeletal survey, etc) and other assessments (ie heamatological, biochemical, endocrinological, ER/PR receptor status, etc) made at baseline, change of treatment modality, every 12-24 weeks on therapy and at endpoint.
Primary outcome [2] 17 0
To compare the two treatment arms in terms of time to response.
Timepoint [2] 17 0
The outcome will be determined via subjective assessments (reported symptoms), objective assessment (ie palpation and measurement, isotope bone scan, x-ray, skeletal survey, etc) and other assessments (ie heamatological, biochemical, endocrinological, ER/PR receptor status, etc) made at baseline, change of treatment modality, every 12-24 weeks on therapy and at endpoint.
Primary outcome [3] 18 0
To compare the two treatment arms in terms of time to treatment failure.
Timepoint [3] 18 0
The outcome will be determined via subjective assessments (reported symptoms), objective assessment (ie palpation and measurement, isotope bone scan, x-ray, skeletal survey, etc) and other assessments (ie heamatological, biochemical, endocrinological, ER/PR receptor status, etc) made at baseline, change of treatment modality, every 12-24 weeks on therapy and at endpoint.
Secondary outcome [1] 31 0
Measuring toxicities
Timepoint [1] 31 0
At baseline, every 12-24 weeks on therapy and at endpoint.
Secondary outcome [2] 32 0
Overall survival
Timepoint [2] 32 0
At baseline, every 12-24 weeks on therapy and at endpoint.
Secondary outcome [3] 33 0
Change of treatment modality.
Timepoint [3] 33 0
At baseline, every 12-24 weeks on therapy and at endpoint.
Secondary outcome [4] 34 0
Using measurements from the subjective, objective and other assessments (ie heamatological, biochemical, endocrinological, ER/PR receptor status, etc)
Timepoint [4] 34 0
At baseline, every 12-24 weeks on therapy and at endpoint.

Eligibility
Key inclusion criteria
a) Histologically or cytologically proven diagnosis of invasive primary breast cancer.b) Locally recurrent or locally advanced breast cancer (a locally advanced breast cancer which is 5cm diameter or greater on clinical measurement or fixed to the chest wall - T1b, T2b, T3b or T4) or distant metastases in bone, lung or soft tissue.c) One measurable or evaluable lesion.d) Pre or peri-menopausal women e) Informed consent to participate in the trial.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Adjuvant hormone or adjuvant anti-hormone therapy within the last 6 months.b) Adjuvant cytotoxic therapy within the last six months. Patients who are amenorrhoeic more than six months after adjuvant cytotoxic therapy should have menopausal status confirmed by serum levels of FSH.c) Prior therapy for advanced disease at any time.d) Concurrent invasive malignancy within the last five years.e) Pregnancyf) Pre-existing sex endocrine disorders.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/1989
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3 0
Self funded/Unfunded
Name [1] 3 0
Australian New Zealand Breast Cancer Trials Group (ANZ BCTG)
Country [1] 3 0
Australia
Funding source category [2] 4 0
Commercial sector/Industry
Name [2] 4 0
Imperial Chemical Industries (ICI) Pharmaceuticals
Country [2] 4 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian New Zealand Breast Cancer Trials Group (ANZ BCTG)
Address
Locked Bag 7, HRMC, NSW 2310
Country
Australia
Secondary sponsor category [1] 3 0
Commercial sector/Industry
Name [1] 3 0
Imperial Chemical Industries (ICI) Pharmaceuticals
Address [1] 3 0
1 Nicholson Street , MELBOURNE , VIC, AUSTRALIA, 3000
Country [1] 3 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 122 0
Hunter Oncology Centre
Ethics committee address [1] 122 0
Ethics committee country [1] 122 0
Australia
Date submitted for ethics approval [1] 122 0
Approval date [1] 122 0
Ethics approval number [1] 122 0
Ethics committee name [2] 123 0
Peter MacCallum Cancer Institute
Ethics committee address [2] 123 0
Ethics committee country [2] 123 0
Australia
Date submitted for ethics approval [2] 123 0
Approval date [2] 123 0
Ethics approval number [2] 123 0
Ethics committee name [3] 124 0
Royal Adelaide Hospital
Ethics committee address [3] 124 0
Ethics committee country [3] 124 0
Australia
Date submitted for ethics approval [3] 124 0
Approval date [3] 124 0
Ethics approval number [3] 124 0
Ethics committee name [4] 125 0
Royal Hobart Hospital
Ethics committee address [4] 125 0
Ethics committee country [4] 125 0
Australia
Date submitted for ethics approval [4] 125 0
Approval date [4] 125 0
Ethics approval number [4] 125 0
Ethics committee name [5] 126 0
Royal Melbourne Hospital
Ethics committee address [5] 126 0
Ethics committee country [5] 126 0
Australia
Date submitted for ethics approval [5] 126 0
Approval date [5] 126 0
Ethics approval number [5] 126 0
Ethics committee name [6] 127 0
Royal Prince Alfred Hospital
Ethics committee address [6] 127 0
Ethics committee country [6] 127 0
Australia
Date submitted for ethics approval [6] 127 0
Approval date [6] 127 0
Ethics approval number [6] 127 0
Ethics committee name [7] 128 0
Sir Charles Gairdner Hospital
Ethics committee address [7] 128 0
Ethics committee country [7] 128 0
Australia
Date submitted for ethics approval [7] 128 0
Approval date [7] 128 0
Ethics approval number [7] 128 0
Ethics committee name [8] 129 0
St Vincent's Hospital Melbourne
Ethics committee address [8] 129 0
Ethics committee country [8] 129 0
Australia
Date submitted for ethics approval [8] 129 0
Approval date [8] 129 0
Ethics approval number [8] 129 0
Ethics committee name [9] 130 0
St Vincent's Hospital Sydney
Ethics committee address [9] 130 0
Ethics committee country [9] 130 0
Australia
Date submitted for ethics approval [9] 130 0
Approval date [9] 130 0
Ethics approval number [9] 130 0

Summary
Brief summary
A phase III study to compare the effect of 'Zoladex' with 'Zoladex plus Nolvadex' in pre- and peri-menopausal patients with advanced breast cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35482 0
Address 35482 0
Country 35482 0
Phone 35482 0
Fax 35482 0
Email 35482 0
Contact person for public queries
Name 10475 0
Administrative Officer, Data Management Department
Address 10475 0
ANZ BCTG Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 10475 0
Australia
Phone 10475 0
+61 2 4925 3068
Fax 10475 0
+ 61 2 4985 0141
Email 10475 0
[email protected]
Contact person for scientific queries
Name 1403 0
Professor John F Forbes
Address 1403 0
ANZ BCTG Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 1403 0
Australia
Phone 1403 0
+ 61 2 4985 0113
Fax 1403 0
+ 61 2 4960 1539
Email 1403 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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