Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00241449




Registration number
NCT00241449
Ethics application status
Date submitted
17/10/2005
Date registered
19/10/2005
Date last updated
6/06/2012

Titles & IDs
Public title
A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer
Scientific title
A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer
Secondary ID [1] 0 0
9238IL/0025
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Tamoxifen

Active comparator: 1 - Tamoxifen

Experimental: 2 - Fulvestrant


Treatment: Drugs: Fulvestrant
intramuscular injection 250 mg

Treatment: Drugs: Tamoxifen
20 mg oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to disease progression (TTP)
Timepoint [1] 0 0
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Secondary outcome [2] 0 0
Duration of response (DoR)
Timepoint [2] 0 0
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Secondary outcome [3] 0 0
Time to treatment failure (TTF)
Timepoint [3] 0 0
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Secondary outcome [5] 0 0
Quality of Life (QOL) and Tolerability.
Timepoint [5] 0 0
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.

Eligibility
Key inclusion criteria
* Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.

Postmenopausal women. Written informed consent to participate in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.

Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.

Treatment with an investigational or non-approved drug within one month of then start of the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Heidelburg
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Heidelburg
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Rosario
Country [20] 0 0
Austria
State/province [20] 0 0
Salzburg
Country [21] 0 0
Austria
State/province [21] 0 0
Wien
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerpen
Country [23] 0 0
Belgium
State/province [23] 0 0
Haine-Saint Paul
Country [24] 0 0
Belgium
State/province [24] 0 0
Hasselt
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Brazil
State/province [26] 0 0
Belo Horizonte
Country [27] 0 0
Brazil
State/province [27] 0 0
Goiania
Country [28] 0 0
Brazil
State/province [28] 0 0
Sao Paulo
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
New Brunswick
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Chicoutimi
Country [34] 0 0
Canada
State/province [34] 0 0
Montreal
Country [35] 0 0
Finland
State/province [35] 0 0
Kotka
Country [36] 0 0
Finland
State/province [36] 0 0
Kuopio
Country [37] 0 0
Finland
State/province [37] 0 0
Rovaniemi
Country [38] 0 0
France
State/province [38] 0 0
Clermont Ferrand
Country [39] 0 0
France
State/province [39] 0 0
Evreux
Country [40] 0 0
France
State/province [40] 0 0
Lyon
Country [41] 0 0
France
State/province [41] 0 0
Montpellier
Country [42] 0 0
France
State/province [42] 0 0
Pierre-Benite
Country [43] 0 0
France
State/province [43] 0 0
Rodez
Country [44] 0 0
France
State/province [44] 0 0
Rouen
Country [45] 0 0
France
State/province [45] 0 0
Tours
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt
Country [47] 0 0
Germany
State/province [47] 0 0
Gottingen
Country [48] 0 0
Germany
State/province [48] 0 0
Rostock
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Pécs
Country [51] 0 0
Hungary
State/province [51] 0 0
Szolnok
Country [52] 0 0
Hungary
State/province [52] 0 0
Székesfehérvár
Country [53] 0 0
Ireland
State/province [53] 0 0
Dublin
Country [54] 0 0
Israel
State/province [54] 0 0
Ashkelon
Country [55] 0 0
Israel
State/province [55] 0 0
Haifa
Country [56] 0 0
Italy
State/province [56] 0 0
Bologna
Country [57] 0 0
Italy
State/province [57] 0 0
Brescia
Country [58] 0 0
Italy
State/province [58] 0 0
Forli
Country [59] 0 0
Italy
State/province [59] 0 0
Genova
Country [60] 0 0
Italy
State/province [60] 0 0
Milano
Country [61] 0 0
Italy
State/province [61] 0 0
Napoli
Country [62] 0 0
Italy
State/province [62] 0 0
Palermo
Country [63] 0 0
Italy
State/province [63] 0 0
Perugia
Country [64] 0 0
Italy
State/province [64] 0 0
Pisa
Country [65] 0 0
Italy
State/province [65] 0 0
Reggio Calabria
Country [66] 0 0
Italy
State/province [66] 0 0
Reggio Emilia
Country [67] 0 0
Italy
State/province [67] 0 0
Rozzano
Country [68] 0 0
Italy
State/province [68] 0 0
Sassari
Country [69] 0 0
Italy
State/province [69] 0 0
Trieste
Country [70] 0 0
Japan
State/province [70] 0 0
Amagasaki
Country [71] 0 0
Japan
State/province [71] 0 0
Fukuoka
Country [72] 0 0
Japan
State/province [72] 0 0
Kitakyusyu
Country [73] 0 0
Japan
State/province [73] 0 0
Kumamoto
Country [74] 0 0
Japan
State/province [74] 0 0
Matsuyama
Country [75] 0 0
Japan
State/province [75] 0 0
Nagoya
Country [76] 0 0
Japan
State/province [76] 0 0
Niigata
Country [77] 0 0
Japan
State/province [77] 0 0
Oita
Country [78] 0 0
Japan
State/province [78] 0 0
Osaka
Country [79] 0 0
Japan
State/province [79] 0 0
Saitama
Country [80] 0 0
Japan
State/province [80] 0 0
Sapporo
Country [81] 0 0
Japan
State/province [81] 0 0
Suita
Country [82] 0 0
Japan
State/province [82] 0 0
Tokyo
Country [83] 0 0
Mexico
State/province [83] 0 0
Guadalajara
Country [84] 0 0
Mexico
State/province [84] 0 0
Mexico, D.F.
Country [85] 0 0
Netherlands
State/province [85] 0 0
Den Haag
Country [86] 0 0
New Zealand
State/province [86] 0 0
Christchurch
Country [87] 0 0
New Zealand
State/province [87] 0 0
Palmerston North
Country [88] 0 0
Poland
State/province [88] 0 0
Bydgoszcz
Country [89] 0 0
Poland
State/province [89] 0 0
Krakow
Country [90] 0 0
Poland
State/province [90] 0 0
Szczecin
Country [91] 0 0
Poland
State/province [91] 0 0
Warszawa
Country [92] 0 0
Portugal
State/province [92] 0 0
Coimbra
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Moscow
Country [94] 0 0
South Africa
State/province [94] 0 0
Cape Town
Country [95] 0 0
South Africa
State/province [95] 0 0
Johannesburg
Country [96] 0 0
South Africa
State/province [96] 0 0
Lyttelton Manor
Country [97] 0 0
Spain
State/province [97] 0 0
Badalona
Country [98] 0 0
Spain
State/province [98] 0 0
Guadalajara
Country [99] 0 0
Spain
State/province [99] 0 0
Madrid
Country [100] 0 0
Spain
State/province [100] 0 0
Málaga
Country [101] 0 0
Taiwan
State/province [101] 0 0
Kaohsiung
Country [102] 0 0
Taiwan
State/province [102] 0 0
Taichung
Country [103] 0 0
Taiwan
State/province [103] 0 0
Tainan
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taipei
Country [105] 0 0
Taiwan
State/province [105] 0 0
Tao-Yuan
Country [106] 0 0
Turkey
State/province [106] 0 0
Istanbul
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Belfast
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Birmingham
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Chelmsford
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Chorley
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Coventry
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Huddersfield
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Leeds
Country [114] 0 0
United Kingdom
State/province [114] 0 0
London
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Luton
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Manchester
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Newcastle Upon Tyne
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Northampton
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Nottingham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Prescot
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Telford
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Whitehaven
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Worthing
Country [124] 0 0
United Kingdom
State/province [124] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
AstraZeneca Oncology Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00241449