A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

Inclusion criteria

• Histologically confirmed breast adenocarcinoma.
• Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
• Prior first-line systemic therapy in the metastatic setting.
• Demonstrated progression of disease by radiological or clinical assessment.
• Female patient, aged ≥18 years old.
• Estimated life expectancy >3 months.
• Normal Left ventricular function
• Adequate haematological, hepatic and renal functions.
• For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
• Ability to swallow oral capsules or tablets.

Exclusion criteria

• More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
• Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
• Active central nervous system metastases, cerebral oedema, and/or progressive growth.
• Patients with impaired cardiac function.
• Uncontrolled arterial hypertension
• Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
• Serum potassium level below Lower Limit of Normal
• Uncontrolled hypothyroidism.
• Pregnant or breastfeeding women.