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

An Open, 3-cohort, Phase II Trial Testing Oral Administration of Lucitanib in Patients With FGFR1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.

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.