CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 298 enrolled
Drug / intervention
exemestane +1 moredrug
Likely dose
Exemestane 25 mg orally once daily or anastrozole 1 mg orally once dailyAI-extracted
Key inclusion· 2
  • ✓Histologically or cytologically confirmed breast cancer at original diagnosis
  • ✓Metastatic, progressive, or locally recurrent inoperable breast cancer at study entry
Key exclusion· 3
  • ✕Prior hormonal therapy (e.g., Tamoxifen, LHRH-agonists)
  • ✕Prior ovariectomy
  • ✕Prior chemotherapy for advanced/recurrent breast cancer

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

Search/NCT00143390
NCT00143390Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

Pfizer·interventional·Posted Sep 2, 2005·Updated Jan 25, 2012

In Brief

A Phase 3 clinical trial evaluating exemestane and anastrozole for Breast Neoplasms. Completed, enrolled 298 participants across 47 sites.

Detailed Summary

To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2005
Enrollment StartApr 1, 2005
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 20.8 years ago

Interventions

exemestanedrug

take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal

anastrozoledrug

take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal