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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/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
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Scientific title
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
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Secondary ID [1]
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0
2005-004263-35
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Secondary ID [2]
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0
CFEM345D2411
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Universal Trial Number (UTN)
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Trial acronym
FACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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0
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Condition category
Condition code
Cancer
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0
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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 - 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
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease Free Survival
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Assessment method [1]
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Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
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Timepoint [1]
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84 months
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Overall survival was defined as the time from the date of randomization to the date of death from any cause.
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Timepoint [1]
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84 months
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Secondary outcome [2]
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0
Time to Development of Distant Metastases
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Assessment method [2]
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Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.
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Timepoint [2]
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84 months
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Secondary outcome [3]
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Time to Development of Contra Lateral Breast Cancer
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Assessment method [3]
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Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.
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Timepoint [3]
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84 months
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Secondary outcome [4]
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Distant Disease-free Survival
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Assessment method [4]
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Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.
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Timepoint [4]
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84 months
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Secondary outcome [5]
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Change From Baseline in Serum Lipid Profiles
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Assessment method [5]
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Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
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Timepoint [5]
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baseline, 6, 12, 24, 36, 48 and 60 months
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Secondary outcome [6]
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Percentage of Participants Who Experienced Clinical Fracture Events
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Assessment method [6]
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The incidence of clinical fractures was analyzed.
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Timepoint [6]
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84 months
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Secondary outcome [7]
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Percentage of Participants Who Experienced Cardiovascular Events
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Assessment method [7]
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The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
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Timepoint [7]
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84 months
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Eligibility
Key inclusion criteria
- Recent primary surgery for breast cancer
- Early stage breast cancer
- Postmenopausal
- Hormone receptor positive
- Positive lymph node involvement
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Minimum age
33
Years
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Maximum age
96
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Metastatic disease
- Presence of contralateral breast cancer including DCIS
- Progression
Other protocol-defined inclusion/exclusion criteria may apply.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/12/2005
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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
1/09/2014
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Sample size
Target
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Accrual to date
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Final
4172
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Garran
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Novartis Investigative Site - Port Macquarie
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Novartis Investigative Site - Randwick
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Novartis Investigative Site - Sydney
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Novartis Investigative Site - Tweed Heads
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Novartis Investigative Site - Waratah
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Novartis Investigative Site - Nambour
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Novartis Investigative Site - Redcliff
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Novartis Investigative Site - Toorak Gardens
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Novartis Investigative Site - Box Hill
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Novartis Investigative Site - Dunedin
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Recruitment hospital [23]
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Novartis Investigative Site - Hamilton
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2444 - Port Macquarie
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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2060 - Sydney
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Recruitment postcode(s) [5]
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2485 - Tweed Heads
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Recruitment postcode(s) [6]
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2298 - Waratah
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Recruitment postcode(s) [7]
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4560 - Nambour
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Recruitment postcode(s) [8]
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4020 - Redcliff
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Recruitment postcode(s) [9]
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5000 - Adelaide
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Recruitment postcode(s) [10]
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5065 - Toorak Gardens
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Recruitment postcode(s) [11]
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3128 - Box Hill
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Recruitment postcode(s) [12]
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3165 - East Bentleigh
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Recruitment postcode(s) [13]
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3076 - Epping
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Recruitment postcode(s) [14]
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3011 - Footscray
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Recruitment postcode(s) [15]
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3199 - Franston
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Recruitment postcode(s) [16]
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3144 - Malvern
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Recruitment postcode(s) [17]
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3050 - Parkville
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Recruitment postcode(s) [18]
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3690 - Wodonga
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Recruitment postcode(s) [19]
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6009 - Nedlands
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6000 - Perth
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Recruitment postcode(s) [21]
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6005 - Perth
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Recruitment postcode(s) [22]
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- Auckland
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Recruitment postcode(s) [23]
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- Dunedin
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Recruitment postcode(s) [24]
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3240 - Hamilton
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Recruitment outside Australia
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Alabama
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Kansas
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North Carolina
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Feldkirch
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Angers cedex 9
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Ireland
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State/province [110]
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Letterkenny
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Country [111]
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Ireland
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State/province [111]
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Limerick
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Country [112]
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Israel
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Jerusalem
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Country [113]
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Israel
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State/province [113]
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Rehovot
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Country [114]
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Israel
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State/province [114]
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Tel-Aviv
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Country [115]
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Israel
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State/province [115]
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Tel-Hashomer
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Country [116]
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Italy
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State/province [116]
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AR
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Country [117]
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Italy
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State/province [117]
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BA
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Country [118]
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Italy
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State/province [118]
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BI
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Country [119]
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Italy
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State/province [119]
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BO
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Country [120]
0
0
Italy
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State/province [120]
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CH
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Country [121]
0
0
Italy
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State/province [121]
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CT
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Country [122]
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Italy
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State/province [122]
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FI
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Country [123]
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0
Italy
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State/province [123]
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FO
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Country [124]
0
0
Italy
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State/province [124]
0
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MI
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Country [125]
0
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Italy
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State/province [125]
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MO
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Country [126]
0
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Italy
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State/province [126]
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0
PN
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Country [127]
0
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Italy
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State/province [127]
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PR
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Country [128]
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Italy
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State/province [128]
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RM
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Country [129]
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Italy
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State/province [129]
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TV
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Country [130]
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0
Italy
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State/province [130]
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UD
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Country [131]
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Italy
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State/province [131]
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VR
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Country [132]
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Italy
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State/province [132]
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Fermo
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Country [133]
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Japan
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State/province [133]
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Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Country [136]
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Japan
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Gunma
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Country [137]
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Japan
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State/province [137]
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Hokkaido
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Country [138]
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Japan
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State/province [138]
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Kanagawa
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Country [139]
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Japan
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Kyoto
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Japan
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Osaka
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Country [141]
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Japan
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State/province [141]
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Saitama
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Country [142]
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Japan
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State/province [142]
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Tochigi
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Country [143]
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Japan
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State/province [143]
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Tokyo
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Country [144]
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Japan
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State/province [144]
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Shizuoka
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Country [145]
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Korea, Republic of
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State/province [145]
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Gyeonggi-do
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Korea, Republic of
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State/province [146]
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Korea
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Country [147]
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Korea, Republic of
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State/province [147]
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Seoul
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Country [148]
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Netherlands
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State/province [148]
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Eindhoven
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Country [149]
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Netherlands
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State/province [149]
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Enschede
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Country [150]
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Netherlands
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State/province [150]
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Nijmegen
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Country [151]
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Netherlands
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State/province [151]
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Rotterdam
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Country [152]
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Netherlands
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State/province [152]
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Veldhoven
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Country [153]
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Norway
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State/province [153]
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Skien
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Country [154]
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Spain
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State/province [154]
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Andalucia
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Country [155]
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Spain
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State/province [155]
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Barcelona
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Country [156]
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Spain
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State/province [156]
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Cantabria
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Country [157]
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Spain
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State/province [157]
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Comunidad Valenciana
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Country [158]
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Spain
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State/province [158]
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Galicia
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Country [159]
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Spain
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State/province [159]
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Alicante
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Country [160]
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Spain
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State/province [160]
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Madrid
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Country [161]
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Spain
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State/province [161]
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Zaragoza
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Country [162]
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Sweden
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State/province [162]
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Lund
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Country [163]
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Sweden
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Stockholm
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Country [164]
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Sweden
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Uppsala
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Country [165]
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Switzerland
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Chur
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Country [166]
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Switzerland
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State/province [166]
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Luzern
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Country [167]
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Switzerland
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State/province [167]
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Schaffhausen
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Country [168]
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Switzerland
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State/province [168]
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Winterthur
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Country [169]
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United Kingdom
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State/province [169]
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East Yorkshire
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Country [170]
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United Kingdom
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State/province [170]
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Middlesex
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Country [171]
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United Kingdom
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Belfast
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Country [172]
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United Kingdom
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Bournemouth
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Country [173]
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United Kingdom
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Bristol
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Country [174]
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United Kingdom
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State/province [174]
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Chelmsford
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Country [175]
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United Kingdom
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State/province [175]
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Colchester
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Country [176]
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United Kingdom
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State/province [176]
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Glasgow
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Country [177]
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United Kingdom
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Liverpool
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Country [178]
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United Kingdom
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London
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Country [179]
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United Kingdom
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Manchester
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Country [180]
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United Kingdom
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State/province [180]
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Merseyside
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Country [181]
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United Kingdom
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State/province [181]
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Plymouth
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Country [182]
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United Kingdom
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State/province [182]
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Rhyl
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Country [183]
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United Kingdom
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State/province [183]
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Sheffiled
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Country [184]
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United Kingdom
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State/province [184]
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Shrewsbury
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Country [185]
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United Kingdom
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females
who recently underwent primary surgery for breast cancer. Patients will be randomized to
letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up
will occur for 5 years after the completion of enrollment for survival and disease status
updates.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00248170
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00248170
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