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

NCT00038103

Last updated date
Study Location
Pfizer Investigational Site
Dallas, Texas, 75204, United States
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1.
    Intervention: Drug: Exemestane
  • Experimental: 2.
    Intervention: Drug: Celecoxib + Exemestane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2010)
111
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   Colombia,   India,   Mexico,   Peru,   Philippines,   United States
Removed Location Countries Portugal
 
Administrative Information
NCT Number  ICMJE NCT00038103
Other Study ID Numbers  ICMJE NQ8-01-02-013
A3191139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP