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

Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) a Non-interventional Trial With Aromasin®

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01050634

Acronym

FAST

Enrollment

980

Registered

2010-01-15

Start date

2005-11-30

Completion date

2009-04-30

Last updated

2010-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Menopausal Women With Early Breast Cancer

Keywords

Aromatase inhibitor, Switch after Tamoxifen, Quality of Life, Safety

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.

Interventions

DRUGAromasin (exemestane)

25mg oral tablet, daily, for \>1yr

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Not applicable.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores	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	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	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	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	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

Participant flow

Participants by arm

Arm	Count
Aromasin (Exemestane) The recommended dosage of exemestane was 25 mg once a day.	924
Total	924

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	42
Overall Study	Death	2
Overall Study	Enrolled, but Not Treated	56
Overall Study	Lost to Follow-up	2
Overall Study	Ongoing at Date of Cut-Off	5
Overall Study	Other	21

Baseline characteristics

Characteristic	Aromasin (Exemestane)
Age, Customized 18-44 years	24 Participants
Age, Customized 45-64 years	450 Participants
Age, Customized >= 65 years	417 Participants
Age, Customized Unspecified	33 Participants
Sex: Female, Male Female	924 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	82 / 924
serious Total, serious adverse events	11 / 924

Outcome results

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

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.