CClinicalTrials.gg
CompletedNCT00649090Updated Sep 29, 2008

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

A Phase 4 interventional study of exemestane in Breast Neoplasms, sponsored by Pfizer. Completed at 63 sites in Belgium. Open to female participants. Per ClinicalTrials.gov, last updated 2008-09-29.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,549
Allocation
Non-randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Neoplasms

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 1,549 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,549 participants (actual)

Study arms

  • Active comparator
    Exemestane group

    Drug: exemestane

Interventions

  • Drugexemestane

    Exemestane 25 mg oral tablet once daily for a maximum of 3 years

06

What researchers measure

Primary outcomes

  1. Assess for serious adverse events

    Time frame: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment

Secondary outcomes

  1. Safety Surveillance Program

    Time frame: Duration of trial

07

Study locations

63 sites
  • Pfizer Investigational Site
    Aalst, 9300, Belgium
  • Pfizer Investigational Site
    Antwerpen, 2020, Belgium
  • Pfizer Investigational Site
    Arlon, 6700, Belgium
  • Pfizer Investigational Site
    Baudour, 7331, Belgium
  • Pfizer Investigational Site
    Bonheiden, 2820, Belgium
  • Pfizer Investigational Site
    Bouge, 5004, Belgium
  • Pfizer Investigational Site
    Boussu, 7300, Belgium
  • Pfizer Investigational Site
    Braine-l'Alleud, 1420, Belgium
  • Pfizer Investigational Site
    Brasschaat, 2930, Belgium
  • Pfizer Investigational Site
    Brugge, 8000, Belgium
  • Pfizer Investigational Site
    Brussels, 1000, Belgium
  • Pfizer Investigational Site
    Brussels, 1020, Belgium
  • Pfizer Investigational Site
    Brussels, 1070, Belgium
  • Pfizer Investigational Site
    Brussels, 1200, Belgium
  • Pfizer Investigational Site
    Brussels, B-1040, Belgium
  • Pfizer Investigational Site
    Brussel, 1000, Belgium
  • Pfizer Investigational Site
    Bruxelles, 1040, Belgium
  • Pfizer Investigational Site
    Bruxelles, 1050, Belgium
  • Pfizer Investigational Site
    Bruxelles, 1180, Belgium
  • Pfizer Investigational Site
    Bruxelles, 1210, Belgium
  • Pfizer Investigational Site
    Charleroi, 6000, Belgium
  • Pfizer Investigational Site
    Chenee, 4032, Belgium
  • Pfizer Investigational Site
    Chimay, 6460, Belgium
  • Pfizer Investigational Site
    Dendermonde, 9200, Belgium
  • Pfizer Investigational Site
    Duffel, 2570, Belgium
  • Pfizer Investigational Site
    Edegem, 2650, Belgium
  • Pfizer Investigational Site
    Eupen, 4700, Belgium
  • Pfizer Investigational Site
    Genk, 3600, Belgium
  • Pfizer Investigational Site
    Gent, 9000, Belgium
  • Pfizer Investigational Site
    Gilly (Charleroi), 6060, Belgium
  • Pfizer Investigational Site
    Gosselies, 6041, Belgium
  • Pfizer Investigational Site
    Halle, 1500, Belgium
  • Pfizer Investigational Site
    Hasselt, 3500, Belgium
  • Pfizer Investigational Site
    Herstal, 4040, Belgium
  • Pfizer Investigational Site
    Hornu, 7301, Belgium
  • Pfizer Investigational Site
    Huy, 4500, Belgium
  • Pfizer Investigational Site
    Kortrijk, 8500, Belgium
  • Pfizer Investigational Site
    La Louviere, 7100, Belgium
  • Pfizer Investigational Site
    Leuven, 3000, Belgium
  • Pfizer Investigational Site
    Libramont, 6800, Belgium
  • Pfizer Investigational Site
    Liege, 4000, Belgium
  • Pfizer Investigational Site
    Lier, 2500, Belgium
  • Pfizer Investigational Site
    Liège, 4000, Belgium
  • Pfizer Investigational Site
    Mechelen, 2800, Belgium
  • Pfizer Investigational Site
    Merksem, 2170, Belgium
  • Pfizer Investigational Site
    Mons, 7000, Belgium
  • Pfizer Investigational Site
    Montigny-le-Tilleul, 6110, Belgium
  • Pfizer Investigational Site
    Mouscron, 7700, Belgium
  • Pfizer Investigational Site
    Namur, 5000, Belgium
  • Pfizer Investigational Site
    Ottignies, 1340, Belgium
  • Pfizer Investigational Site
    Rocourt, 4000, Belgium
  • Pfizer Investigational Site
    Roeselare, 8800, Belgium
  • Pfizer Investigational Site
    Seraing, 4100, Belgium
  • Pfizer Investigational Site
    Sint-Niklaas, 9100, Belgium
  • Pfizer Investigational Site
    Soignies, 7060, Belgium
  • Pfizer Investigational Site
    Tongeren, 3700, Belgium
  • Pfizer Investigational Site
    Torhout, 8820, Belgium
  • Pfizer Investigational Site
    Tournai, 7500, Belgium
  • Pfizer Investigational Site
    Turnhout, 2300, Belgium
  • Pfizer Investigational Site
    Verviers, 4800, Belgium
  • Pfizer Investigational Site
    Waregem, 8790, Belgium
  • Pfizer Investigational Site
    Wilrijk, 2610, Belgium
  • Pfizer Investigational Site
    Yvoir, 5530, Belgium
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00649090
Lead sponsor
Pfizer
First posted
Apr 1, 2008
Start date
Mar 2005
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Sep 29, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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