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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01050634
First received: January 13, 2010
Last updated: June 23, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Post Menopausal Women With Early Breast Cancer
Drug: Aromasin (exemestane)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) a Non-interventional Trial With Aromasin®

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 980
Study Start Date: November 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational Drug: Aromasin (exemestane)
25mg oral tablet, daily, for >1yr
Other Name: Aromasin, exemestane

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050634

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01050634     History of Changes
Other Study ID Numbers: A5991079
Study First Received: January 13, 2010
Results First Received: April 26, 2010
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
Aromatase inhibitor
Switch after Tamoxifen
Quality of Life
Safety

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014