Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGlucitanib
Sponsors
Breast International Group
Institut de Recherches Internationales Servier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Every 8 weeks | Tumor evaluation every 8 weeks throughout the study |
Countries
Australia, Belgium, Canada, France, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed