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Trial record 1 of 1 for:    NCT00038103
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Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

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ClinicalTrials.gov Identifier: NCT00038103
Recruitment Status : Completed
First Posted : May 30, 2002
Results First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 29, 2002
First Posted Date  ICMJE May 30, 2002
Results First Submitted Date  ICMJE March 27, 2009
Results First Posted Date  ICMJE February 25, 2010
Last Update Posted Date February 25, 2010
Study Start Date  ICMJE January 2002
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2010)
Number of Subjects With Clinical Benefit [ Time Frame: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV) ]
Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2010)
  • Number of Subjects With Objective Response [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]
    Objective tumor response includes subjects with CR or PR according to RECIST.
  • Duration of Clinical Benefit [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]
    Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.
  • Duration of Objective Response (in Subjects With CR or PR) [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]
    Time from the first objective documentation of response until the first objective documentation of tumor progression.
  • Duration of Long-Term SD [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV ]
    Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.
  • Time to Tumor Progression [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV ]
    Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.
  • Time to Treatment Failure [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ]
    Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.
  • Survival [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death ]
    Time from randomization to date of death (any cause).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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