NCT00754325

Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

Phase II Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Dasatinib	Tablets, Oral, 100 mg, once daily (QD), upto 2 years
DRUG	Fulvestrant	Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-11-01
• Completion: 2014-01-01
• First posted: 2008-09-17
• Last updated: 2016-05-26
• Results posted: 2016-05-25

Locations

28 sites across 1 country: United States