NCT00927511

A Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC)

A Phase II Study, Comparing a Dose-Titration Regimen of Fulvestrant With the Approved Dosing Regimen in Postmenopausal Patients With Hormone-Responsive Advanced Breast Cancer (ABC) (Fulvestrant Intensity Density Study - Studio FIDeS)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Female
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

In post-menopausal metastatic hormone-responsive breast cancer women. This study is a two arm randomized trial to evaluate the effectiveness of dose-titration regimen of fulvestrant compared with the approved dosing regimen. Patients will be randomized to one of the following treatment arms: Arm A: Fulvestrant 500 mg days 0, 14, 28, then 250 mg every 2 weeks for 5 administrations, then 250 mg every 28 days, until progression or unacceptable toxicity Arm B: Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity

Detailed description

Arm A: Fulvestrant 500 mg days 0, 14, 28, then 250 mg every 2 weeks for 5 administrations, then 250 mg every 28 days, until progression or unacceptable toxicity Arm B: Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant	Fulvestrant 500 mg days 0, 14, 28, then 250 mg every 2 weeks for 5 administrations, then 250 mg every 28 days, until progression or unacceptable toxicity vs Fulvestrant 250 mg every 28 days until progression or unacceptable toxicity

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-06-25
• Last updated: 2011-07-22

Locations

1 site across 1 country: Italy