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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038103
• Other study ID #: NQ8-01-02-013
• Secondary ID: A3191139
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2002
• Last updated: February 11, 2010
• Start date: January 2002
• Est. completion date: March 2008

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Namur
Belgium	Pfizer Investigational Site	Wilrijk
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Canada	Pfizer Investigational Site	Sydney	Nova Scotia
Colombia	Pfizer Investigational Site	Bogota	Bogota . DC
Colombia	Pfizer Investigational Site	Cali
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
India	Pfizer Investigational Site	Mumbai	Maharashtra
India	Pfizer Investigational Site	Pune	Maharashtra
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Mexico	Distrito Federal
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Philippines	Pfizer Investigational Site	Manila
United States	Pfizer Investigational Site	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Colombia,  India,  Mexico,  Peru,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Clinical Benefit		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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Time to Treatment Failure		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	No
Secondary	Survival		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	No

External Links

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