Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lucitanib | Drug | Lucitanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lucitanib
- description
- Hard gelatine capsules of 2,5, 5 and 10 mg or film coated tablets of 5 and 7,5 mg. 5 to 10 mg orally on a daily basis until unacceptable toxicity according to the investigator, disease progression or withdrawal of consent
- interventionNames
- Drug: lucitanib
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Every 8 weeks
- description
- Tumor evaluation every 8 weeks throughout the study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDHui R, Pearson RM, Cortes Castan J, Campbell C, Poirot C, Azim HA Jr, Fumagalli R, Lambertini M, Daly F, Arahmani A, Garcia-Perez J, Aftimos PG, Bedard P, Xuereb RG, Loibl S, Loi U, Pierrat MJ, Turner NC, Andre F, Curigliano G. Ann Oncol. 2018 Oct;29(Supplement 8):VIII93. doi: https://doi.org/10.1093/annonc/mdy272.281
- BACKGROUNDLiao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18. PMID 35844029