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Trial record 1 of 1 for:    NCT01050634
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Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) (FAST)

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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

Tracking Information
First Submitted Date January 13, 2010
First Posted Date January 15, 2010
Results First Submitted Date April 26, 2010
Results First Posted Date July 23, 2010
Last Update Posted Date July 23, 2010
Study Start Date November 2005
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2010)
  • 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 ]
    10 single-item in LASA format(100mm scale): Physical wellbeing (good to lousy); Mood (happy to miserable); Tiredness, Hot flushes, Feeling sick, Use of arm restricted - all none to a lot; Appetite (good to none); Effort to cope with illness (no effort to great deal of effort); Supported by people (much to not at all); Rating life in current condition (perfect to worst health). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where best QoL=0mm, worst QoL =100mm, and negative changes from baseline=improvement in QoL.Score range=0-100
  • Change From Baseline in Thickness of Endometrium [ Time Frame: Baseline, Month 12 ]
    Ultrasound measurement. New derived variable for normalization of endometrium thickness: 1 = Endometrium thickness <=5mm 0 = Endometrium thickness >5mm
  • Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26 [ Time Frame: Baseline, Month 12 ]
    Assessment of severity of 13 items (Being irritable, Sweats, Vaginal discharge, dryness, and itching/irritation, Sleep disturbance, Feeling dizzy, Headaches, Bone or joint pain, Troubled by weight gain, Loss of sexual interest, Difficulties in becoming aroused - all from none to severe, and Bothered by treatment related difficulties (not at all to severely). Individual items scored by measuring distance in mm between left scale anchor and patient's mark, where no severity=0mm, maximum severity=100mm and negative changes from baseline=lessening of severity.Score range=0-100
  • 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 ]
    Items: 1.General health 1=poor to 5=excellent 2.Limited moderate activities & 3.Climbing of stairs 1=lot to 3=not at all 4.Accomplished less & 5.Limited in kind of work due to physical health, 6.Accomplished less & 7.Work done less carefully due to emotional problems 1=yes, 2=no 8.Pain interfered with work 1=extremely to 5=not at all 9.Felt calm & 10.Had lot of energy 1=none to 6=all time 11.Felt downhearted & 12.Physical health/emotional problems interfered with social activities 1=all time to 6=none of the time. Higher scores=better QoL, positive changes from baseline=improvement in QoL.
  • Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26 [ Time Frame: Baseline, Month 12 ]
    The 3 LASA items concerning vaginal symptoms (discharge, dryness, itching/irritation) were combined as the sum of these 3 items. Lower scores corresponded to better QoL, with negative changes from baseline corresponding to improvements in vaginal symptoms. Total overall score range=0-300, Best score=0, Worst score=300
Original Primary Outcome Measures
 (submitted: January 14, 2010)
  • Quality of Life (questionnaire). [ Time Frame: 12 months ]
  • Thickness of Endometrium [ Time Frame: 6 months, 12months ]
  • Incidence of AEs [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
Official Title Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) a Non-interventional Trial With Aromasin®
Brief Summary

Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International Breast Cancer Study Group) questionnaire.

Change of the endometrium after switching from tamoxifen to Aromasin® (exemestane).

Deeper knowledge of Adverse Events during routine administration.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy
Condition Post Menopausal Women With Early Breast Cancer
Intervention Drug: Aromasin (exemestane)
25mg oral tablet, daily, for >1yr
Other Name: Aromasin, exemestane
Study Groups/Cohorts Observational
Intervention: Drug: Aromasin (exemestane)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2010)
980
Original Actual Enrollment
 (submitted: January 14, 2010)
984
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy.

Exclusion Criteria:

  • Not applicable.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01050634
Other Study ID Numbers A5991079
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2010