NCT00038103

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_2

Geographic Reach
9 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2002

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 25, 2010

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

Enrollment Period

6.2 years

First QC Date

May 29, 2002

Results QC Date

March 27, 2009

Last Update Submit

February 11, 2010

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Clinical Benefit

    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 Outcomes (7)

  • Number of Subjects With Objective Response

    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

    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)

    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

    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

    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

  • +2 more secondary outcomes

Study Arms (2)

1.

ACTIVE COMPARATOR
Drug: Exemestane

2.

EXPERIMENTAL
Drug: Celecoxib + Exemestane

Interventions

ExemestaneDRUG

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

Also known as: Aromasin
1.
Celecoxib + ExemestaneDRUG

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

Also known as: Celebrex, Aromasin
2.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Pfizer Investigational Site

Dallas, Texas, 75204, United States

Location

Pfizer Investigational Site

Antwerp, 2020, Belgium

Location

Pfizer Investigational Site

Brussels, 1000, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Namur, 5000, Belgium

Location

Pfizer Investigational Site

Wilrijk, 2610, Belgium

Location

Pfizer Investigational Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 01509-900, Brazil

Location

Pfizer Investigational Site

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Pfizer Investigational Site

Bogotá, Bogota . DC, Colombia

Location

Pfizer Investigational Site

Cali, Colombia

Location

Pfizer Investigational Site

Hyderabad, Andhra Pradesh, 500 082, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 029, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 012, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 41101, India

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44280, Mexico

Location

Pfizer Investigational Site

Mexico City, Mexico City, 07760, Mexico

Location

Pfizer Investigational Site

Lima, Lima Province, 11, Peru

Location

Pfizer Investigational Site

Lima, Lima Province, 34, Peru

Location

Pfizer Investigational Site

Manila, 1000, Philippines

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestaneCelecoxib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2002

First Posted

May 30, 2002

Study Start

January 1, 2002

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

February 25, 2010

Results First Posted

February 25, 2010

Record last verified: 2010-02

Locations

CA(1)IN(4)ME(2)BE(5)BR(2)US(1)CO(2)PE(2)PH(1)