Breast Cancer Clinical Trial
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
Summary
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.
Full Description
Lucitanib is a selective, orally available tyrosine kinase inhibitor targeting FGFR1-3, VEGFR1-3, and PDGFRα and β, with activity in relevant cell lines and animal models.
The first in human trial of lucitanib demonstrated that daily dosing with lucitanib can provide durable clinical responses in patients with FGFR1- or 11q (FGF3, FGF4, Cyclin D1, or FGF19)-amplified breast cancer. RECIST partial responses (PRs) were also observed in patients not known to have FGF abnormalities.
Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in breast cancer patients with and without alterations of the FGF pathway.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
Prior treatment with standard first line therapy in the metastatic setting
Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q amplification status
Demonstrated progression of disease by radiological or clinical assessment (Measurable disease according to RECIST Version 1.1 is NOT required for enrollment)
Estimated life expectancy >6 months
Exclusion Criteria:
Current or recent treatment with biologic anticancer therapies
Ongoing AEs from prior anticancer therapies
Active central nervous system (CNS) metastases
Clinically significant or uncontrolled hypertension or cardiac disease
Females who are pregnant or breastfeeding
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There are 32 Locations for this study
Sedona Arizona, 86336, United States
Bakersfield California, 93309, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Redondo Beach California, 90277, United States
San Francisco California, 94115, United States
Santa Maria California, 93454, United States
New Haven Connecticut, 06519, United States
Deerfield Beach Florida, 33442, United States
Hollywood Florida, 33021, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Lafayette Indiana, 47905, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02115, United States
Las Vegas Nevada, 89169, United States
Voorhees New Jersey, 08043, United States
Bronx New York, 10469, United States
New York New York, 10065, United States
New York New York, 10065, United States
Cleveland Ohio, 44106, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78731, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Norfolk Virginia, 23502, United States
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