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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Dallas, Texas, 75204 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal female patient with histologically or cytologically confirmed breast
cancer having progressed on Tamoxifen.

- Advanced disease: patients with advanced breast carcinoma with disease progression who
had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced
disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending
on receptor status; or progressed within 12 months from completion of adjuvant
treatment with Tamoxifen.

- at least one measurable lesion

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- More than one previous chemotherapy and/or more than one hormonotherapy for advanced
disease.

- Previous hormonotherapy for advanced disease other than Tamoxifen.

- Myocardial infarction within previous 6 mo

NCT00038103
Pfizer
Completed
Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

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Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Exemestane
    Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
    Other Name: Aromasin
  • 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.
    Other Name: Celebrex, Aromasin
  • Active Comparator: 1.
    Intervention: Drug: Exemestane
  • Experimental: 2.
    Intervention: Drug: Celecoxib + Exemestane
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.
  • Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.
  • at least one measurable lesion

Exclusion Criteria:

  • More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.
  • Previous hormonotherapy for advanced disease other than Tamoxifen.
  • Myocardial infarction within previous 6 mo
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Canada,   Colombia,   India,   Mexico,   Peru,   Philippines,   United States
Portugal
 
NCT00038103
NQ8-01-02-013
A3191139
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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