CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 111 enrolled
Drug / intervention
Exemestane +1 moredrug
Likely dose
Exemestane 25 mg orally once daily, with or without celecoxib 400 mg daily (200 mg twice daily)AI-extracted
Key inclusion· 3
  • ✓Postmenopausal female with histologically or cytologically confirmed breast cancer that progressed on tamoxifen
  • ✓Advanced disease with progression after ≥8 weeks of tamoxifen for advanced disease; OR during adjuvant tamoxifen (≥6-12 months); OR within 12 months of completing adjuvant tamoxifen
  • ✓At least one measurable lesion
Key exclusion· 4
  • ✕More than one prior chemotherapy regimen for advanced disease
  • ✕More than one prior hormone therapy regimen for advanced disease
  • ✕Prior hormone therapy for advanced disease other than tamoxifen
  • ✕Myocardial infarction within the previous 6 months

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

Search/NCT00038103
NCT00038103Phase 2Completed
CompareCT.gov

Open-Label, Multicentre, Controlled Study Of Exemestane (Aromasin®) With Or Without Celecoxib (Celebrex®) In Postmenopausal Women With Advanced Breast Cancer (ABC) Having Progressed On Tamoxifen

Pfizer·interventional·Posted May 30, 2002·Updated Feb 25, 2010

In Brief

A Phase 2 clinical trial evaluating Exemestane and Celecoxib + Exemestane for Breast Neoplasms. Completed, enrolled 111 participants across 20 sites in 9 countries.

Detailed Summary

This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesBelgium, Brazil, Canada, Colombia, India, Mexico, Peru, Philippines, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 30, 2002
Enrollment StartJan 1, 2002
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 24.1 years ago

Interventions

Exemestanedrug

Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.

Celecoxib + Exemestanedrug

Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.