Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

NCT00038103 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2010-02-25

Study results available
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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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Exemestane

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

DRUG

Celecoxib + Exemestane

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • India
  • Mexico
  • Peru
  • Philippines

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00038103 on ClinicalTrials.gov