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Exemestane Adjuvant Safety Surveillance Program
NCT00649090Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2005
- Primary completion
- Apr 2007
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- exemestane
- Conditions
- breast cancer
01
Overview
Phase 4, open-label, single-arm trial of exemestane in breast cancer, sponsored by Pfizer. Primary endpoint: Serious Adverse Events. Started Mar 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Exemestane group
Exemestane 25 mg oral tablet once daily
03
Who it enrols
Postmenopausal women with estrogen receptor-positive early breast cancer who remain disease-free after 2-3 years of tamoxifen treatment.
04
Endpoints
Primary
Serious Adverse Events
Secondary
Safety Surveillance Program
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