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Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer (FACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248170
First Posted: November 3, 2005
Last Update Posted: April 19, 2016
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: September 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Letrozole
Drug: Anastrozole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants, who had recently undergone surgery, were randomly assigned in 1:1 ratio to letrozole or anastrozole. Participants received daily treatment until disease recurrence/relapse or for a maximum of 5 years. Participants underwent post-treatment long term follow-up for disease-free survival and overall survival.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Participant Flow:   Overall Study
    Letrozole   Anastrozole
STARTED   2078   2094 
Intent-to-treat (ITT)   2061   2075 
Safety Set   2049   2062 
COMPLETED   1317   1286 
NOT COMPLETED   761   808 
Withdrawal by Subject                71                79 
Protocol Violation                35                30 
Lost to Follow-up                28                35 
Disease progression                196                216 
Death                28                47 
Adverse Event                311                296 
Administrative problems                22                25 
Abnormal test procedure(s) result                49                61 
Abnormal laboratory values                4                0 
Protocol deviation                17                19 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily
Total Total of all reporting groups

Baseline Measures
   Letrozole   Anastrozole   Total 
Overall Participants Analyzed 
[Units: Participants]
 2061   2075   4136 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (8.48)   63.1  (8.45)   63.2  (8.46) 
Gender, Customized 
[Units: Participants]
     
Female   2061   2075   4136 


  Outcome Measures
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1.  Primary:   Disease Free Survival   [ Time Frame: 84 months ]

Measure Type Primary
Measure Title Disease Free Survival
Measure Description 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.
Time Frame 84 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2061   2075 
Disease Free Survival 
[Units: Months]
Median (95% Confidence Interval)
 NA [1] 
 (84.14 to N/A) 
 NA [1] 
[1] The median was not reached and therefore, could not be calculated.


Statistical Analysis 1 for Disease Free Survival
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.3150
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   Overall Survival   [ Time Frame: 84 months ]

Measure Type Secondary
Measure Title Overall Survival
Measure Description Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time Frame 84 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2061   2075 
Overall Survival 
[Units: Months]
Median (95% Confidence Interval)
 NA [1]   NA [1] 
[1] The median was not reached and therefore, the median could not be calculated.

No statistical analysis provided for Overall Survival



3.  Secondary:   Time to Development of Distant Metastases   [ Time Frame: 84 months ]

Measure Type Secondary
Measure Title Time to Development of Distant Metastases
Measure Description 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.
Time Frame 84 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2061   2075 
Time to Development of Distant Metastases 
[Units: Months]
Median (95% Confidence Interval)
 NA [1] 
 (84.14 to N/A) 
 NA [1] 
[1] The median was not reached and therefore, the median could not be calculated.

No statistical analysis provided for Time to Development of Distant Metastases



4.  Secondary:   Time to Development of Contra Lateral Breast Cancer   [ Time Frame: 84 months ]

Measure Type Secondary
Measure Title Time to Development of Contra Lateral Breast Cancer
Measure Description 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.
Time Frame 84 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2061   2075 
Time to Development of Contra Lateral Breast Cancer 
[Units: Months]
Median (95% Confidence Interval)
 NA [1]   NA [1] 
[1] The median was not reached and therefore, the median could not be calculated.

No statistical analysis provided for Time to Development of Contra Lateral Breast Cancer



5.  Secondary:   Distant Disease-free Survival   [ Time Frame: 84 months ]

Measure Type Secondary
Measure Title Distant Disease-free Survival
Measure Description 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.
Time Frame 84 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2061   2075 
Distant Disease-free Survival 
[Units: Months]
Median (95% Confidence Interval)
 NA [1] 
 (84.14 to N/A) 
 NA [1] 
[1] The median was not reached and therefore, the median could not be calculated.

No statistical analysis provided for Distant Disease-free Survival



6.  Secondary:   Change From Baseline in Serum Lipid Profiles   [ Time Frame: baseline, 6, 12, 24, 36, 48 and 60 months ]

Measure Type Secondary
Measure Title Change From Baseline in Serum Lipid Profiles
Measure Description Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
Time Frame baseline, 6, 12, 24, 36, 48 and 60 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2049   2062 
Change From Baseline in Serum Lipid Profiles 
[Units: mg/dL]
Mean (95% Confidence Interval)
   
6 months   5.643 
 (5.584 to 5.701) 
 5.553 
 (5.495 to 5.611) 
12 months   5.569 
 (5.510 to 5.629) 
 5.511 
 (5.452 to 5.570) 
24 months   5.508 
 (5.445 to 5.572) 
 5.436 
 (5.373 to 5.499) 
36 months   5.429 
 (5.359 to 5.500) 
 5.427 
 (5.357 to 5.497) 
48 months   5.395 
 (5.323 to 5.468) 
 5.366 
 (5.293 to 5.438) 
60 months   5.375 
 (5.300 to 5.451) 
 5.368 
 (5.292 to 5.443) 

No statistical analysis provided for Change From Baseline in Serum Lipid Profiles



7.  Secondary:   Percentage of Participants Who Experienced Clinical Fracture Events   [ Time Frame: 84 months ]

Measure Type Secondary
Measure Title Percentage of Participants Who Experienced Clinical Fracture Events
Measure Description The incidence of clinical fractures was analyzed.
Time Frame 84 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2049   2062 
Percentage of Participants Who Experienced Clinical Fracture Events 
[Units: Percentage of participants]
 9.3   8.1 

No statistical analysis provided for Percentage of Participants Who Experienced Clinical Fracture Events



8.  Secondary:   Percentage of Participants Who Experienced Cardiovascular Events   [ Time Frame: 84 months ]

Measure Type Secondary
Measure Title Percentage of Participants Who Experienced Cardiovascular Events
Measure Description The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Time Frame 84 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.

Reporting Groups
  Description
Letrozole 2.5 mg by mouth (p.o.) once daily
Anastrozole 1 mg p.o. once daily

Measured Values
   Letrozole   Anastrozole 
Participants Analyzed 
[Units: Participants]
 2049   2062 
Percentage of Participants Who Experienced Cardiovascular Events 
[Units: Percentage of participants]
   
Ischemic heart disease   2.4   1.5 
Cardiac failures   1.5   0.7 
Cerebrovascular accidents   1.6   1.5 
Thromboembolic events   1.2   1.2 

No statistical analysis provided for Percentage of Participants Who Experienced Cardiovascular Events




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00248170     History of Changes
Other Study ID Numbers: CFEM345D2411
2005-004263-35 ( EudraCT Number )
EUDRACT number 2005-004263-35 ( Registry Identifier: EUDRACT )
First Submitted: November 2, 2005
First Posted: November 3, 2005
Results First Submitted: September 8, 2015
Results First Posted: October 9, 2015
Last Update Posted: April 19, 2016