FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
1. Capsules containing 5, 10 or 15 mg of lucitanib taken orally on a daily basis, treatment duration at the investigator's discretion
2. Concomitant intramuscular injection of fulvestrant 500 mg on a
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Menopausal women aged 18 years old or over 2. Histologically confirmed breast adenocarcinoma 3. Relapsing during or after treatment with fulvestrant 4. Tumour progression at study entry demonstrated by radiological assessment 5. Adequate haematological, hepatic and renal functions
Exclusion criteria
Exclusion criteria: 1. Previously treated with more than three chemotherapy regimen in the metastatic/advanced setting 2. Previous treatment with bevacizumab within 3 months before the first day of lucitanib administration 3. Active central nervous system metastases, cerebral oedema, and/or progressive growth 4. Patients with impaired cardiac function 5. Serum potassium level below lower limit of normal 6. Uncontrolled hypothyroidism 7. Pregnant or breastfeeding women 8. Patient with any other concomitant severe and/or uncontrolled medical condition that would, in the investigators' opinion, contraindicate patient participation in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of lucitanib in combination with fulvestrant, at the end of dose allocation cycles 2. Safety profile of lucitanib in combination with fulvestrant at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical benefit rate (CBR), progression-free survival (PFS) and duration of response over the study 2. Pharmacokinetic and pharmacodynamic profile of lucitanib in combination with fulvestrant at each cycle | — |
Countries
France
Outcome results
None listed