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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression
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) - It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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- Concord
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- Heidelburg
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex
(tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer.
Patients will be treated until disease progression or until the investigator has determined
that treatment is not in the best interest of the patient, whichever occurs first.
Trial website
https://clinicaltrials.gov/show/NCT00241449
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

Summary results
Other publications