FACT anastrozole monotherapy versus maximal oestrogen blockade with anstrozole and fulvestrant combination therapy an open randomized, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localized tumour. - FACT

• Conditions: Hormone Receptor Positive Advanced Breast Cancer; MedDRA version: 6.1Level: PTClassification code 10057654

• Registration Number: EUCTR2006-000320-14-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 512

Inclusion Criteria

1. Postmenopausal woman 2. Documented positive hormone receptor status ER ve and/or PgR ve of primary or metastatic tumour tissue 3. Patients with misurable or not misurable advanced disease 4. Histological/cytological confirmation of breast cancer 5. Provision of written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous systemic therapy for advanced breast cancer. 2. Platelets 100 109 / L 3. Total bilirubin 1.5 ULRR Upper limit of reference range 4. ALT or AST transamminase 2.5 ULRR if no demonstrable liver metastases or 5 ULRR in presence of liver metastases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare time to progression of patients treated with fulvestrant with time to progression of patients treated with combination of fulvestrant and anastrozole.;Secondary Objective: 1. To compare the objective response rate of patients treated with fulvestrant with the objective response rate of patients treated with combination of fulvestrant and anastrozole 2. To compare the time to treatment failure of patients treated with fulvestrant with the time to treatment failure of patients treated with combination of fulvestrant and anastrozole 3. To assess the safety and tolerability of fulvestrant treatment compared with combination of fulvestrant and anastrozole;Primary end point(s): Time to progression