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

Phase 2

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Celecoxib + Exemestane; Drug: Exemestane

• Registration Number: NCT00038103
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2002-05-29
• Study First Submitted QC: 2002-05-29
• Study First Posted: 2002-05-30
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-03-27
• Status Verified: 2010-02
• Results First Submitted QC: 2010-02-11
• Last Update Submitted: 2010-02-11
• Results First Posted: 2010-02-25
• Last Update Posted: 2010-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.	Celecoxib + Exemestane	-
1.	Exemestane	-

Primary Outcome Measures

Name	Time	Method
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)	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.

Secondary Outcome Measures

Name	Time	Method
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	Objective tumor response includes subjects with CR or PR according to RECIST.
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	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)	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	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	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	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	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).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇭 Manila, Philippines