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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
  Hide Participant Flow

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
  Show All Outcome Measures

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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