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

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
Unknown	21
Ongoing at Date of Cut-Off	5

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	Aromasin (Exemestane)
Number of Participants [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

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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 ]

Measure Type	Primary
Measure Title	Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores
Measure Description	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
Time Frame	Baseline, Month 12
Safety Issue	No

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.
Full Analysis Set (FAS)=Subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy measurement=Number of participants analyzed. Missing values were imputed by last observation carried forward (LOCF). Subjects analyzed for single item (n)=Subjects with Baseline and Final Visit (LOCF) scores for the item

Reporting Groups

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

Measured Values

	Aromasin (Exemestane)
Number of Participants Analyzed [units: participants]	860
Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores [units: mm] Mean ± Standard Deviation
Physical Well-Being (n=773)	-5.82 ± 23.58
Mood (n=775)	-8.37 ± 21.88
Tiredness (n=774)	-8.22 ± 23.20
Appetite (n=776)	-7.04 ± 21.35
Hot Flushes (n=772)	-5.98 ± 24.65
Feeling Sick (Nausea/Vomiting) (n=774)	-2.06 ± 15.52
Effort to Cope with Illness (n=773)	-11.0 ± 22.95
Feel Supported by People Close to You (n=774)	-2.09 ± 18.23
Operation Restricts Use of Arm (n=771)	-4.96 ± 18.64
Imagine Rest of Life in Current Condition (n=767)	-5.42 ± 17.69

No statistical analysis provided for Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores

2. Primary:

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

Measure Type	Primary
Measure Title	Change From Baseline in Thickness of Endometrium
Measure Description	Ultrasound measurement. New derived variable for normalization of endometrium thickness: 1 = Endometrium thickness <=5mm 0 = Endometrium thickness >5mm
Time Frame	Baseline, Month 12
Safety Issue	No

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.
FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) values.

Reporting Groups

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

Measured Values

	Aromasin (Exemestane)
Number of Participants Analyzed [units: participants]	437
Change From Baseline in Thickness of Endometrium [units: mm] Mean ± Standard Deviation	-1.1 ± 6.1

No statistical analysis provided for Change From Baseline in Thickness of Endometrium

3. Primary:

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

Measure Type	Primary
Measure Title	Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26
Measure Description	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
Time Frame	Baseline, Month 12
Safety Issue	No

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.
FAS=Number of participants analyzed. Missing values were imputed by LOCF. Number of subjects analyzed for single LASA item (n)=Number of subjects with Baseline and Final Visit (LOCF) scores for the single item.

Reporting Groups

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

Measured Values

	Aromasin (Exemestane)
Number of Participants Analyzed [units: participants]	860
Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26 [units: mm] Mean ± Standard Deviation
Being Irritable (n=771)	-5.22 ± 20.58
Sweats (Including Night Sweats) (n=771)	-7.44 ± 23.63
Vaginal Discharge (n=766)	-3.45 ± 17.67
Vaginal Dryness (n=765)	-4.98 ± 26.44
Vaginal Itching/Vaginal Irritation (n=765)	-1.70 ± 20.89
Sleep Disturbance (n=769)	-5.35 ± 22.48
Feeling Dizzy (n=768)	-2.42 ± 19.28
Headaches (n=771)	-2.11 ± 18.97
Bone or Joint Pain (n=772)	1.67 ± 26.49
Troubled by Weight Gain (n=770)	-5.39 ± 21.69
Loss of Sexual Interest (n=741)	-3.25 ± 25.64
Overall Bothered by Treatment (n=718)	-6.59 ± 22.48
Had Difficulties Becoming Aroused? (n=345)	-3.37 ± 19.94

No statistical analysis provided for Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26

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 ]

Measure Type	Primary
Measure Title	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
Measure Description	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.
Time Frame	Baseline, Month 12
Safety Issue	No

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.
FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.

Reporting Groups

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

Measured Values

	Aromasin (Exemestane)
Number of Participants Analyzed [units: participants]	758
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 [units: Scores on a scale] Mean ± Standard Deviation
Mental Summary Scale	2.93 ± 8.90
Physical Summary Scale	2.02 ± 7.14

No statistical analysis provided for 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

5. Primary:

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

Measure Type	Primary
Measure Title	Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26
Measure Description	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
Time Frame	Baseline, Month 12
Safety Issue	No

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.
FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.

Reporting Groups

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

Measured Values

	Aromasin (Exemestane)
Number of Participants Analyzed [units: participants]	756
Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26 [units: Scores on a scale (mm)] Mean ± Standard Deviation	-10.2 ± 47.31

No statistical analysis provided for Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26

Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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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

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