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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00248170




Registration number
NCT00248170
Ethics application status
Date submitted
2/11/2005
Date registered
3/11/2005
Date last updated
19/04/2016

Titles & IDs
Public title
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Scientific title
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Secondary ID [1] 0 0
2005-004263-35
Secondary ID [2] 0 0
CFEM345D2411
Universal Trial Number (UTN)
Trial acronym
FACE
Linked study record

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

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

Experimental: Letrozole - 2.5 mg by mouth (p.o.) once daily

Active comparator: Anastrozole - 1 mg p.o. once daily


Treatment: Drugs: Letrozole
2.5 mg tablets

Treatment: Drugs: Anastrozole
1 mg tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival
Timepoint [1] 0 0
84 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
84 months
Secondary outcome [2] 0 0
Time to Development of Distant Metastases
Timepoint [2] 0 0
84 months
Secondary outcome [3] 0 0
Time to Development of Contra Lateral Breast Cancer
Timepoint [3] 0 0
84 months
Secondary outcome [4] 0 0
Distant Disease-free Survival
Timepoint [4] 0 0
84 months
Secondary outcome [5] 0 0
Change From Baseline in Serum Lipid Profiles
Timepoint [5] 0 0
baseline, 6, 12, 24, 36, 48 and 60 months
Secondary outcome [6] 0 0
Percentage of Participants Who Experienced Clinical Fracture Events
Timepoint [6] 0 0
84 months
Secondary outcome [7] 0 0
Percentage of Participants Who Experienced Cardiovascular Events
Timepoint [7] 0 0
84 months

Eligibility
Key inclusion criteria
* Recent primary surgery for breast cancer
* Early stage breast cancer
* Postmenopausal
* Hormone receptor positive
* Positive lymph node involvement
Minimum age
33 Years
Maximum age
96 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Metastatic disease
* Presence of contralateral breast cancer including DCIS
* Progression

Other protocol-defined inclusion/exclusion criteria may apply.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
4172
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Garran
Recruitment hospital [2] 0 0
Novartis Investigative Site - Port Macquarie
Recruitment hospital [3] 0 0
Novartis Investigative Site - Randwick
Recruitment hospital [4] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [5] 0 0
Novartis Investigative Site - Tweed Heads
Recruitment hospital [6] 0 0
Novartis Investigative Site - Waratah
Recruitment hospital [7] 0 0
Novartis Investigative Site - Nambour
Recruitment hospital [8] 0 0
Novartis Investigative Site - Redcliff
Recruitment hospital [9] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [10] 0 0
Novartis Investigative Site - Toorak Gardens
Recruitment hospital [11] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [12] 0 0
Novartis Investigative Site - East Bentleigh
Recruitment hospital [13] 0 0
Novartis Investigative Site - Epping
Recruitment hospital [14] 0 0
Novartis Investigative Site - Footscray
Recruitment hospital [15] 0 0
Novartis Investigative Site - Franston
Recruitment hospital [16] 0 0
Novartis Investigative Site - Malvern
Recruitment hospital [17] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [18] 0 0
Novartis Investigative Site - Wodonga
Recruitment hospital [19] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [20] 0 0
Novartis Investigative Site - Perth
Recruitment hospital [21] 0 0
Novartis Investigative Site - Auckland
Recruitment hospital [22] 0 0
Novartis Investigative Site - Dunedin
Recruitment hospital [23] 0 0
Novartis Investigative Site - Hamilton
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2060 - Sydney
Recruitment postcode(s) [5] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment postcode(s) [7] 0 0
4560 - Nambour
Recruitment postcode(s) [8] 0 0
4020 - Redcliff
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [13] 0 0
3076 - Epping
Recruitment postcode(s) [14] 0 0
3011 - Footscray
Recruitment postcode(s) [15] 0 0
3199 - Franston
Recruitment postcode(s) [16] 0 0
3144 - Malvern
Recruitment postcode(s) [17] 0 0
3050 - Parkville
Recruitment postcode(s) [18] 0 0
3690 - Wodonga
Recruitment postcode(s) [19] 0 0
6009 - Nedlands
Recruitment postcode(s) [20] 0 0
6000 - Perth
Recruitment postcode(s) [21] 0 0
6005 - Perth
Recruitment postcode(s) [22] 0 0
- Auckland
Recruitment postcode(s) [23] 0 0
- Dunedin
Recruitment postcode(s) [24] 0 0
3240 - Hamilton
Recruitment outside Australia
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Washington
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Austria
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Feldkirch
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Friesach
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Graz
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Güssing
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Innsbruck
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Leoben
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Linz
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Salzburg
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Vienna
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Villach
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Wels
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Wien
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Montpellier
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Nice
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Perpignan
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Périgueux Cédex
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Rennes Cedex
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Strasbourg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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 are available at https://clinicaltrials.gov/study/NCT00248170