Second Line Breast Cancer Trial

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Advanced Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635713

9238IL/0021

D6995C00021

Details and patient eligibility

About

The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Enrollment: 588 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• postmenopausal women with confirmation of breast cancer
• objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

Exclusion criteria

• presence of life-threatening metastatic visceral disease
• previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
• more than 1 prior endocrine medical treatment for advanced breast cancer .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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588 participants in 2 patient groups

1

Experimental group

Description:

Faslodex 125mg and Arimidex 1 mg

Treatment:

Drug: Fulvestrant

Drug: Anastrozole

Drug: Fulvestrant

2

Experimental group

Description:

Faslodex 250mg and Arimidex 1mg

Treatment:

Drug: Fulvestrant

Drug: Anastrozole

Drug: Fulvestrant