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

February 11, 2010 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Namur, Belgium, 5000
        • Pfizer Investigational Site
      • Wilrijk, Belgium, 2610
        • Pfizer Investigational Site
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 01509-900
        • Pfizer Investigational Site
  • Canada
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Pfizer Investigational Site
  • Colombia
      • Cali, Colombia
        • Pfizer Investigational Site
    • Bogota . DC
      • Bogota, Bogota . DC, Colombia
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 082
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 029
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 41101
        • Pfizer Investigational Site
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 07760
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, 11
        • Pfizer Investigational Site
      • Lima, Peru, 34
        • Pfizer Investigational Site
  • Philippines
      • Manila, Philippines, 1000
        • Pfizer Investigational Site
  • United States
    • Texas
      • Dallas, Texas, United States, 75204
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1.
Drug: Exemestane
Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
Other Names:
  • Aromasin
Experimental: 2.
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 Names:
  • Celebrex, Aromasin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV
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.
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 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.
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 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.
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
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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 29, 2002

First Submitted That Met QC Criteria

May 29, 2002

First Posted (Estimate)

May 30, 2002

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NQ8-01-02-013
  • A3191139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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