CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Exemestane +1 moredrug
Likely dose
Exemestane 25 mg orally per day plus fulvestrant 250 mg IM starting on Day 8 and then every 28 daysAI-extracted
Key inclusion· 6
  • ✓Metastatic or locally advanced breast cancer
  • ✓Hormone receptor-positive disease (ER and/or PR positive >10% by immunohistochemistry)
  • ✓Postmenopausal status
  • ✓No more than 1 prior chemotherapy regimen for stage IV metastatic disease
Key exclusion· 9
  • ✕Prior exemestane or fulvestrant therapy
  • ✕Ongoing or active infection
  • ✕Symptomatic congestive heart failure
  • ✕Unstable angina pectoris or cardiac arrhythmia

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

Search/NCT00201864
NCT00201864Phase 2Completed
CompareCT.gov

Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Ohio State University Comprehensive Cancer Center·interventional·Posted Sep 20, 2005·Updated Jul 26, 2018

In Brief

A Phase 2 clinical trial evaluating Exemestane and Fulvestrant for Breast Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2012
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.8 years ago

Interventions

Exemestanedrug

25 mg orally per day

Fulvestrantdrug

250 mg IM starting on Day 8 and then every 28 days.