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

Pfizer111 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

111

Conditions

Breast Neoplasms

Interventions

ExemestaneDRUG

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

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Pfizer Investigational Site

Dallas, Texas, United States

Pfizer Investigational Site

Antwerp, Belgium

Outcomes

Primary Outcomes

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.

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)

Secondary Outcomes

Number of Subjects With Objective Response

Objective tumor response includes subjects with CR or PR according to RECIST.

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

Duration of Clinical Benefit

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.

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

Duration of Objective Response (in Subjects With CR or PR)

Time from the first objective documentation of response until the first objective documentation of tumor progression.

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

Duration of Long-Term SD

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 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.