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Randomized Trial Of Exemestan...

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

Last Updated: 2014-05-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4740 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-02-28

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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B

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

A

Group Type EXPERIMENTAL

Exemestane

Intervention Type DRUG

Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Interventions

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Tamoxifen

Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Intervention Type DRUG

Exemestane

Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Green Valley, Arizona, United States

Site Status