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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
0
0
9238IL/0025
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
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Metastasis
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Time to disease progression (TTP)
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Assessment method [1]
0
0
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
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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.
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Secondary outcome [1]
0
0
Objective response rate (ORR)
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Assessment method [1]
0
0
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
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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.
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Secondary outcome [2]
0
0
Duration of response (DoR)
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Assessment method [2]
0
0
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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.
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Secondary outcome [3]
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0
Time to treatment failure (TTF)
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Assessment method [3]
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0
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Timepoint [3]
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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.
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Secondary outcome [4]
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0
Overall survival (OS)
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Assessment method [4]
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0
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Timepoint [4]
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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.
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Secondary outcome [5]
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Quality of Life (QOL) and Tolerability.
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Assessment method [5]
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Timepoint [5]
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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.
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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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/1998
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2012
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Camperdown
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Research Site - Concord
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Research Site - Heidelburg
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Research Site - Melbourne
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- Camperdown
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- Concord
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- Heidelburg
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- Melbourne
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Name
AstraZeneca
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00241449
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Contacts
Principal investigator
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AstraZeneca Oncology Medical Science Director, MD
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00241449
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