CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,598 enrolled
Drug / intervention
exemestane +1 moredrug
Likely dose
exemestane 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00016432
NCT00016432Phase 3Completed
CompareCT.gov

A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy

NSABP Foundation Inc·interventional·Posted Jan 27, 2003·Updated Apr 19, 2011

In Brief

A Phase 3 clinical trial evaluating exemestane and Placebo for Breast Cancer. Completed, enrolled 1,598 participants across 162 sites in 3 countries.

Detailed Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMay 1, 2001
Primary CompletionOct 1, 2003
Study CompletionFeb 1, 2011
TodayJul 1, 2026
Enrollment to primary: 2.4 yearsPosted 23.4 years ago

Interventions

exemestanedrug

25 mg for 5 years

Placebodrug

Placebo