Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Exemestane; Drug: Tamoxifen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00038467

96-OEXE-031

A5991012

Details and patient eligibility

About

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.

Enrollment: 4,740 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• unresectable breast cancer
• ER negative primary tumor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,740 participants in 2 patient groups

B

Active Comparator group

Treatment:

Drug: Tamoxifen

A

Experimental group

Treatment:

Drug: Exemestane