NCT01484041

Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer

A Phase I/II Trial of TKI258 (Dovitinib) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for women with confirmed hormone receptor positive HER-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor. The purpose of this study is to determine how well these medications work together and/or if they have any side effects in patients with hormone-receptor positive metastatic breast cancer who have demonstrated progression of disease after first line hormonal therapy. This research is being done to determine if taking an already approved medicine (aromatase inhibitor) in combination with a new medication (dovitinib) results in better outcomes for patients with this disease. Both dovitinib and an aromatase inhibitor are pills that will be taken at home.

Detailed description

This is a Phase I/Phase II open-label single arm trial of dovitinib in combination with anastrozole 1 mg daily, exemestane 25 mg daily, or letrozole 2.5 mg daily. Study subjects will receive the aromatase inhibitor on which they had previously derived clinical benefit.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Dovitinib	Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
DRUG	Aromatase Inhibitors	Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2011-12-02
• Last updated: 2018-02-09
• Results posted: 2016-09-20

Locations

1 site across 1 country: United States