CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Exemestane +2 moredrug
Likely dose
Exemestane 25 mg orally once per day for 16 weeks plus celecoxib 400 mg orally twice per dayAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed breast cancer, Stage II-IV
  • ✓ER and/or PR positive disease
  • ✓Postmenopausal status
  • ✓ECOG Performance Status 0-1
Key exclusion· 7
  • ✕Known history of aspirin or NSAID-induced asthma, urticaria, or allergic reactions; or allergy to sulfonamides requiring ER/hospitalization
  • ✕History of myocardial infarction or other thrombotic events
  • ✕Inflammatory breast cancer (skin edema or ulceration)
  • ✕Significant renal dysfunction (serum creatinine > 1.5 x ULN)

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

Search/NCT00201773
NCT00201773Phase 2Completed
CompareCT.gov

A Phase II Trial of Exemestane (Aromasin) in Combination With Celecoxib (Celebrex) as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer

Ohio State University Comprehensive Cancer Center·interventional·Posted Sep 20, 2005·Updated Jun 30, 2015

In Brief

A Phase 2 clinical trial evaluating Exemestane, Celecoxib, and 1 other intervention for Breast Cancer. Completed, enrolled 22 participants across 1 site.

Detailed Summary

To test whether the addition of the COX-2 inhibitor, celecoxib, will decrease the gene expression of CYP19 in breast cancers collected from postmenopausal women that receive neoadjuvant exemestane.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJul 1, 2003
Primary CompletionNov 1, 2007
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Exemestanedrug

25 mg orally once per day for 16 weeks.

Celecoxibdrug

given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.

Correlative studiesother