Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

Pfizer

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: exemestane; Drug: anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143390

A5991048

Details and patient eligibility

About

To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.

Enrollment: 298 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.

Exclusion criteria

• Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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298 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: exemestane

2

Experimental group

Treatment:

Drug: anastrozole