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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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Post Menopausal Women With Early Breast Cancer
Intervention Drug: Aromasin (exemestane)
Enrollment 980
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aromasin (Exemestane)
Hide Arm/Group Description The recommended dosage of exemestane was 25mg once a day.
Period Title: Overall Study
Started 980
Received Treatment 924
Completed 852
Not Completed 128
Reason Not Completed
Enrolled, but Not Treated             56
Death             2
Adverse Event             42
Lost to Follow-up             2
Other             21
Ongoing at Date of Cut-Off             5
Arm/Group Title Aromasin (Exemestane)
Hide Arm/Group Description The recommended dosage of exemestane was 25 mg once a day.
Overall Number of Baseline Participants 924
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 924 participants
18-44 years 24
45-64 years 450
>= 65 years 417
Unspecified 33
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 924 participants
Female
924
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aromasin (Exemestane)
Hide Arm/Group Description:
The recommended dosage of exemestane was 25 mg once a day.
Overall Number of Participants Analyzed 860
Mean (Standard Deviation)
Unit of Measure: mm
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)
2.Primary Outcome
Title Change From Baseline in Thickness of Endometrium
Hide Description

Ultrasound measurement. New derived variable for normalization of endometrium thickness:

1 = Endometrium thickness <=5mm 0 = Endometrium thickness >5mm

Time Frame Baseline, Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) values.
Arm/Group Title Aromasin (Exemestane)
Hide Arm/Group Description:
The recommended dosage of exemestane was 25 mg once a day.
Overall Number of Participants Analyzed 437
Mean (Standard Deviation)
Unit of Measure: mm
-1.1  (6.1)
3.Primary Outcome
Title Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aromasin (Exemestane)
Hide Arm/Group Description:
The recommended dosage of exemestane was 25 mg once a day.
Overall Number of Participants Analyzed 860
Mean (Standard Deviation)
Unit of Measure: mm
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)
4.Primary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.
Arm/Group Title Aromasin (Exemestane)
Hide Arm/Group Description:
The recommended dosage of exemestane was 25 mg once a day.
Overall Number of Participants Analyzed 758
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Mental Summary Scale 2.93  (8.90)
Physical Summary Scale 2.02  (7.14)
5.Primary Outcome
Title Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.
Arm/Group Title Aromasin (Exemestane)
Hide Arm/Group Description:
The recommended dosage of exemestane was 25 mg once a day.
Overall Number of Participants Analyzed 756
Mean (Standard Deviation)
Unit of Measure: Scores on a scale (mm)
-10.2  (47.31)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Observational
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Observational
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Observational
Affected / at Risk (%)
Total   11/924 (1.19%) 
Cardiac disorders   
Cardiac failure  1  1/924 (0.11%) 
Gastrointestinal disorders   
Gastric ulcer  1  1/924 (0.11%) 
Injury, poisoning and procedural complications   
Fall  1  1/924 (0.11%) 
Femoral neck fracture  1  2/924 (0.22%) 
Investigations   
Blood pressure increased  1  1/924 (0.11%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/924 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Brain neoplasm  1  1/924 (0.11%) 
Breast cancer recurrent  1  1/924 (0.11%) 
Metastases to bone  1  2/924 (0.22%) 
Tumour invasion  1  1/924 (0.11%) 
Nervous system disorders   
Carpal tunnel syndrome  1  1/924 (0.11%) 
Psychiatric disorders   
Confusional state  1  1/924 (0.11%) 
Vascular disorders   
Thrombosis  1  1/924 (0.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Observational
Affected / at Risk (%)
Total   82/924 (8.87%) 
Ear and labyrinth disorders   
Presbyacusis  1  1/924 (0.11%) 
Endocrine disorders   
Autoimmune thyroiditis  1  1/924 (0.11%) 
Eye disorders   
Cataract  1  1/924 (0.11%) 
Visual acuity reduced  1  1/924 (0.11%) 
Gastrointestinal disorders   
Abdominal pain upper  1  1/924 (0.11%) 
Diarrhoea  1  3/924 (0.32%) 
Gastritis  1  1/924 (0.11%) 
Gastrooesophageal reflux disease  1  1/924 (0.11%) 
Nausea  1  3/924 (0.32%) 
Vomiting  1  1/924 (0.11%) 
General disorders   
General physical health deterioration  1  1/924 (0.11%) 
Oedema  1  1/924 (0.11%) 
Oedema peripheral  1  1/924 (0.11%) 
Immune system disorders   
Hypersensitivity  1  1/924 (0.11%) 
Seasonal allergy  1  1/924 (0.11%) 
Infections and infestations   
Cystitis  1  1/924 (0.11%) 
Erysipelas  1  1/924 (0.11%) 
Herpes zoster  1  1/924 (0.11%) 
Nasopharyngitis  1  1/924 (0.11%) 
Urinary tract infection  1  1/924 (0.11%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  1/924 (0.11%) 
Rib fracture  1  1/924 (0.11%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/924 (0.11%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  21/924 (2.27%) 
Arthritis reactive  1  1/924 (0.11%) 
Arthropathy  1  2/924 (0.22%) 
Bone pain  1  10/924 (1.08%) 
Joint stiffness  1  1/924 (0.11%) 
Myalgia  1  3/924 (0.32%) 
Nodal osteoarthritis  1  1/924 (0.11%) 
Osteopenia  1  1/924 (0.11%) 
Osteoporosis  1  2/924 (0.22%) 
Rheumatoid arthritis  1  1/924 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to bone  1  1/924 (0.11%) 
Metastases to liver  1  1/924 (0.11%) 
Metastases to lung  1  1/924 (0.11%) 
Metastases to lymph nodes  1  1/924 (0.11%) 
Nervous system disorders   
Carpal tunnel syndrome  1  3/924 (0.32%) 
Dizziness  1  2/924 (0.22%) 
Headache  1  3/924 (0.32%) 
Hypoaesthesia  1  1/924 (0.11%) 
Memory impairment  1  1/924 (0.11%) 
Sensory disturbance  1  1/924 (0.11%) 
Visual field defect  1  1/924 (0.11%) 
Psychiatric disorders   
Confusional state  1  1/924 (0.11%) 
Initial insomnia  1  1/924 (0.11%) 
Sleep disorder  1  1/924 (0.11%) 
Thinking abnormal  1  1/924 (0.11%) 
Reproductive system and breast disorders   
Menometrorrhagia  1  1/924 (0.11%) 
Menopausal symptoms  1  1/924 (0.11%) 
Vaginal haemorrhage  1  1/924 (0.11%) 
Vulvovaginal dryness  1  1/924 (0.11%) 
Vulvovaginal pruritus  1  1/924 (0.11%) 
Skin and subcutaneous tissue disorders   
Acne  1  1/924 (0.11%) 
Alopecia  1  5/924 (0.54%) 
Dermatitis allergic  1  1/924 (0.11%) 
Hyperhidrosis  1  2/924 (0.22%) 
Pruritus  1  1/924 (0.11%) 
Rash  1  2/924 (0.22%) 
Social circumstances   
Menopause  1  2/924 (0.22%) 
Vascular disorders   
Hot flush  1  6/924 (0.65%) 
Peripheral vascular disorder  1  1/924 (0.11%) 
Varicose vein  1  1/924 (0.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01050634     History of Changes
Other Study ID Numbers: A5991079
First Submitted: January 13, 2010
First Posted: January 15, 2010
Results First Submitted: April 26, 2010
Results First Posted: July 23, 2010
Last Update Posted: July 23, 2010