drugset
drugset / Trial / 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

NCT00754325 ↗

Phase 2 Completed 100 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-09
Primary completion
2011-11
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator 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 Unknown 500 mg Intramuscular
Comparator Tablets, Oral, 100 mg, once daily (QD), upto 2 years Unknown 100 mg Oral

Indications

female breast carcinoma