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

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT01050634

Acronym / sponsor ID

FAST / A5991079

Conditions

Post Menopausal Women With Early Breast Cancer

Keywords

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

Study type

Observational

Recruitment status

Completed

Enrolment

980 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

Nov 2005

Primary completion

Apr 2009 (actual)

Study completion

Apr 2009 (actual)

First posted

15 Jan 2010 (estimated)

Results

Posted 23 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Case only

Time perspective

Prospective

Number of arms

1

Who may qualify

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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

2. 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

3. 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

4. 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.

5. 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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.