A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649090
• Other study ID #: A5991077
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2008
• Last updated: September 25, 2008
• Start date: March 2005
• Est. completion date: April 2007

Study information

• Verified date: September 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Directorate General for Medicinal product FPS of Public Health, Food Chain Security and Env
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1549
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postmenopausal patients

• Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years

• Estrogen receptor positive breast cancer patients

• Patients who remain free from disease following treatment with tamoxifen

Exclusion Criteria:

• Patients taking other drugs for the adjuvant treatment of breast cancer

• Patients taking hormone replacement therapy

• Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• exemestane
Exemestane 25 mg oral tablet once daily for a maximum of 3 years

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Aalst
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Arlon
Belgium	Pfizer Investigational Site	Baudour
Belgium	Pfizer Investigational Site	Bonheiden
Belgium	Pfizer Investigational Site	Bouge
Belgium	Pfizer Investigational Site	Boussu
Belgium	Pfizer Investigational Site	Braine-l'Alleud
Belgium	Pfizer Investigational Site	Brasschaat
Belgium	Pfizer Investigational Site	Brugge
Belgium	Pfizer Investigational Site	Brussel
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Charleroi
Belgium	Pfizer Investigational Site	Chenee
Belgium	Pfizer Investigational Site	Chimay
Belgium	Pfizer Investigational Site	Dendermonde
Belgium	Pfizer Investigational Site	Duffel
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Eupen
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Gilly (Charleroi)
Belgium	Pfizer Investigational Site	Gosselies
Belgium	Pfizer Investigational Site	Halle
Belgium	Pfizer Investigational Site	Hasselt
Belgium	Pfizer Investigational Site	Herstal
Belgium	Pfizer Investigational Site	Hornu
Belgium	Pfizer Investigational Site	Huy
Belgium	Pfizer Investigational Site	Kortrijk
Belgium	Pfizer Investigational Site	La Louviere
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Libramont
Belgium	Pfizer Investigational Site	Liege
Belgium	Pfizer Investigational Site	Liège
Belgium	Pfizer Investigational Site	Lier
Belgium	Pfizer Investigational Site	Mechelen
Belgium	Pfizer Investigational Site	Merksem
Belgium	Pfizer Investigational Site	Mons
Belgium	Pfizer Investigational Site	Montigny-le-Tilleul
Belgium	Pfizer Investigational Site	Mouscron
Belgium	Pfizer Investigational Site	Namur
Belgium	Pfizer Investigational Site	Ottignies
Belgium	Pfizer Investigational Site	Rocourt
Belgium	Pfizer Investigational Site	Roeselare
Belgium	Pfizer Investigational Site	Seraing
Belgium	Pfizer Investigational Site	Sint-Niklaas
Belgium	Pfizer Investigational Site	Soignies
Belgium	Pfizer Investigational Site	Tongeren
Belgium	Pfizer Investigational Site	Torhout
Belgium	Pfizer Investigational Site	Tournai
Belgium	Pfizer Investigational Site	Turnhout
Belgium	Pfizer Investigational Site	Verviers
Belgium	Pfizer Investigational Site	Waregem
Belgium	Pfizer Investigational Site	Wilrijk
Belgium	Pfizer Investigational Site	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess for serious adverse events		Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment	Yes
Secondary	Safety Surveillance Program		Duration of trial	Yes

External Links

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