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Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) (FAST)

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.
ClinicalTrials.gov Identifier: NCT01050634
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : July 23, 2010
Last Update Posted : July 23, 2010
Sponsor:
Information provided by:
Pfizer

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Post Menopausal Women With Early Breast Cancer
Intervention: Drug: Aromasin (exemestane)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Aromasin (Exemestane) The recommended dosage of exemestane was 25mg once a day.

Participant Flow:   Overall Study
    Aromasin (Exemestane)
STARTED   980 
Received Treatment   924 
COMPLETED   852 
NOT COMPLETED   128 
Enrolled, but Not Treated                56 
Death                2 
Adverse Event                42 
Lost to Follow-up                2 
Other                21 
Ongoing at Date of Cut-Off                5 



  Baseline Characteristics

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
Aromasin (Exemestane) The recommended dosage of exemestane was 25 mg once a day.

Baseline Measures
   Aromasin (Exemestane) 
Overall Participants Analyzed 
[Units: Participants]
 924 
Age, Customized 
[Units: Participants]
 
18-44 years   24 
45-64 years   450 
>= 65 years   417 
Unspecified   33 
Gender 
[Units: Participants]
 
Female   924 
Male   0 


  Outcome Measures

1.  Primary:   Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores   [ Time Frame: Baseline, Month 12 ]

2.  Primary:   Change From Baseline in Thickness of Endometrium   [ Time Frame: Baseline, Month 12 ]

3.  Primary:   Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26   [ Time Frame: Baseline, Month 12 ]

4.  Primary:   Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores   [ Time Frame: Baseline, Month 12 ]

5.  Primary:   Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26   [ Time Frame: Baseline, Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01050634     History of Changes
Other Study ID Numbers: A5991079
First Submitted: January 13, 2010
First Posted: January 15, 2010
Results First Submitted: April 26, 2010
Results First Posted: July 23, 2010
Last Update Posted: July 23, 2010