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

NCT01050634 | Completed Results

• 1 other identifier: A5991079
• Study Type: observational
• Target: 980
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Menopausal Women With Early Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (5)

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

  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

  Baseline, Month 12

• Change From Baseline in Thickness of Endometrium

  Ultrasound measurement. New derived variable for normalization of endometrium thickness: 1 = Endometrium thickness \<=5mm 0 = Endometrium thickness \>5mm

  Baseline, Month 12

• Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26

  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

  Baseline, Month 12

• 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.

  Baseline, Month 12

• Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26

  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

  Baseline, Month 12

Study Arms (1)

Observational

Drug: Aromasin (exemestane)

Interventions

Aromasin (exemestane) DRUG

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

Also known as: Aromasin, exemestane

Observational

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Interventions

exemestane

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: November 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 23, 2010
• Results First Posted: July 23, 2010

Record last verified: 2010-06