Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
(IES Trial)
Recruiting in Palo Alto (17 mi)
+323 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
Stay on Your Current Meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
Eligibility Criteria
Inclusion Criteria
postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease
Treatment Details
Interventions
- Exemestane (Aromatase Inhibitor)
- Tamoxifen (Selective Estrogen Receptor Modulator)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: AExperimental Treatment1 Intervention
Group II: BActive Control1 Intervention
Exemestane is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Aromasin for:
- Early breast cancer
- Advanced breast cancer
🇺🇸 Approved in United States as Aromasin for:
- Early breast cancer
- Advanced breast cancer
🇨🇦 Approved in Canada as Aromasin for:
- Early breast cancer
- Advanced breast cancer
🇯🇵 Approved in Japan as Aromasin for:
- Early breast cancer
- Advanced breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Pfizer Investigational SiteLakewood, CO
Pfizer Investigational SiteOcala, FL
Pfizer Investigational SiteBoulder, CO
Pfizer Investigational SiteFort Collins, CO
More Trial Locations
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Who Is Running the Clinical Trial?
PfizerLead Sponsor
International Collaborative Cancer GroupCollaborator