Clinical trial NCT00649090: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 1549
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assess for serious adverse events
timeFrame: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment
Secondary outcomes:
measure: Safety Surveillance Program
timeFrame: Duration of trial
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Pfizer Investigational Site
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Arlon
country: Belgium
facility: Pfizer Investigational Site
city: Baudour
country: Belgium
facility: Pfizer Investigational Site
city: Bonheiden
country: Belgium
facility: Pfizer Investigational Site
city: Bouge
country: Belgium
facility: Pfizer Investigational Site
city: Boussu
country: Belgium
facility: Pfizer Investigational Site
city: Braine-l'Alleud
country: Belgium
facility: Pfizer Investigational Site
city: Brasschaat
country: Belgium
facility: Pfizer Investigational Site
city: Brugge
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Brussel
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Charleroi
country: Belgium
facility: Pfizer Investigational Site
city: Chenee
country: Belgium
facility: Pfizer Investigational Site
city: Chimay
country: Belgium
facility: Pfizer Investigational Site
city: Dendermonde
country: Belgium
facility: Pfizer Investigational Site
city: Duffel
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Eupen
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Gilly (Charleroi)
country: Belgium
facility: Pfizer Investigational Site
city: Gosselies
country: Belgium
facility: Pfizer Investigational Site
city: Halle
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Herstal
country: Belgium
facility: Pfizer Investigational Site
city: Hornu
country: Belgium
facility: Pfizer Investigational Site
city: Huy
country: Belgium
facility: Pfizer Investigational Site
city: Kortrijk
country: Belgium
facility: Pfizer Investigational Site
city: La Louviere
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Libramont
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Lier
country: Belgium
facility: Pfizer Investigational Site
city: Liège
country: Belgium
facility: Pfizer Investigational Site
city: Mechelen
country: Belgium
facility: Pfizer Investigational Site
city: Merksem
country: Belgium
facility: Pfizer Investigational Site
city: Mons
country: Belgium
facility: Pfizer Investigational Site
city: Montigny-le-Tilleul
country: Belgium
facility: Pfizer Investigational Site
city: Mouscron
country: Belgium
facility: Pfizer Investigational Site
city: Namur
country: Belgium
facility: Pfizer Investigational Site
city: Ottignies
country: Belgium
facility: Pfizer Investigational Site
city: Rocourt
country: Belgium
facility: Pfizer Investigational Site
city: Roeselare
country: Belgium
facility: Pfizer Investigational Site
city: Seraing
country: Belgium
facility: Pfizer Investigational Site
city: Sint-Niklaas
country: Belgium
facility: Pfizer Investigational Site
city: Soignies
country: Belgium
facility: Pfizer Investigational Site
city: Tongeren
country: Belgium
facility: Pfizer Investigational Site
city: Torhout
country: Belgium
facility: Pfizer Investigational Site
city: Tournai
country: Belgium
facility: Pfizer Investigational Site
city: Turnhout
country: Belgium
facility: Pfizer Investigational Site
city: Verviers
country: Belgium
facility: Pfizer Investigational Site
city: Waregem
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Yvoir
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: