Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer
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.
Drug: Aromatase Inhibitors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of TKI258 (Dovitinib) in Combination With an Aromatase Inhibitor in Patients With Metastatic Breast Cancer|
- Clinical Benefit Rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Complete response, partial response, or stable disease at 24 weeks from trial entry as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression
- Recommended Phase 2 Dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]The dose of dovitinib at which 1 or less subjects experience a dose limiting toxicity when administered every day for 5 days followed by 2 days off schedule in combination with an aromatase inhibitor
- Number of Participants With Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Number of participants experiencing adverse events
- Pharmacodynamic Effects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Expression of pFGFR, pFRS2, pERK in tumor tissue and VEGF, bFGF, PLGF, sVEGFR1/2 and FGF23 levels in plasma
- Progression-free Survival [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Length of time from study entry until progressive disease
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Dovitinib plus aromatase inhibitors
Dovitinib with aromatase inhibitor
Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
Other Name: TKI258Drug: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484041
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Claudine Isaacs, MD||Georgetown University|