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.

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

• submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
• Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

After Marketing Authorisation in EEA or US if the study is used for the approval.

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.