A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer (FIRST)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: anastrozole; Drug: fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00274469

D6995C00006

FIRST

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

Enrollment: 205 patients

Sex: Female

Ages: 45 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Exclusion criteria

• Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

1

Experimental group

Description:

Fulvestrant

Treatment:

Drug: fulvestrant

2

Active Comparator group

Description:

Anastrozole

Treatment:

Drug: anastrozole