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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Celecoxib + Exemestane; Drug: Exemestane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038103

A3191139

NQ8-01-02-013

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

1.

Active Comparator group

Treatment:

Drug: Exemestane

2.

Experimental group

Treatment:

Drug: Celecoxib + Exemestane