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

• 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: Pfizer
• Information provided by: Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Post Menopausal Women With Early Breast Cancer	Drug: Aromasin (exemestane)

Study Design

• Study Type: Observational
• Actual Enrollment: 980 participants
• 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®
• Study Start Date: November 2005
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: April 2009

Groups and Cohorts

Group/Cohort	Intervention/treatment
Observational	Drug: Aromasin (exemestane); 25mg oral tablet, daily, for >1yr; Other Name: Aromasin, exemestane

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes 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

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• ClinicalTrials.gov Identifier: NCT01050634
• Other Study ID Numbers: A5991079
• First Posted: January 15, 2010
• Results First Posted: July 23, 2010
• Last Update Posted: July 23, 2010
• Last Verified: June 2010

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Exemestane; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs