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 (FINESSE)
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ClinicalTrials.gov Identifier: NCT02053636 |
Recruitment Status :
Completed
First Posted : February 4, 2014
Last Update Posted : April 26, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: lucitanib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | March 2017 |
Actual Study Completion Date : | April 4, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: lucitanib
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 |
Drug: lucitanib |
- Objective response rate (ORR) [ Time Frame: Every 8 weeks ]Tumor evaluation every 8 weeks throughout the study

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053636
Australia | |
Peter MacCallum Cancer Centre | |
East Melbourne, Australia | |
Westmead Hospital | |
Westmead, Australia, 2145 | |
Belgium | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Cliniques Universitaires St. Luc Oncology - Breast Clinic | |
Bruxelles, Belgium, 1200 | |
Grand Hôpital de Charleroi Oncologie-Hématologie | |
Charleroi, Belgium, 6000 | |
UZ Leuven Campus Gasthuisberg Dept. of General Medical | |
Leuven, Belgium, 3000 | |
Clinique Sainte-Elisabeth Médecine Interne - Oncologie | |
Namur, Belgium, 5000 | |
Canada | |
McGill University Department of Oncologie - Clinical Reserach Program | |
Montreal, Canada, H2W 1S6 | |
Princess Margaret Cancer Centre | |
Toronto, Canada, M5G 2M9 | |
University Health Network - Princess Margaret Hospital | |
Toronto, Canada, M5G 2M9 | |
France | |
Institut Claudius Regaud Dpt d'Oncologie Médicale | |
Toulouse, France, 31059 | |
Institut Gustave Roussy | |
Villejuif Cedex, France, 94805 | |
Institut Gustave Roussy Dépt d'oncologie - Cancer du sein | |
Villejuif, France, 94805 | |
Germany | |
Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum | |
Essen, Germany, 45136 | |
KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe | |
Offenbach, Germany, 63069 | |
Klinikum Offenbach | |
Offenbach, Germany, 63069 | |
Hungary | |
Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt. | |
Budapest, Hungary, 1122 | |
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet | |
Debrecen, Hungary, 4032 | |
Italy | |
Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative | |
Milano, Italy, 20141 | |
Istituto Europeo di Oncologia | |
Milan, Italy, 20141 | |
Spain | |
H. Valle de Hebrón Servicio de Oncología | |
Barcelona, Spain, 08035 | |
Hospital Universitario Val d'Hebròn | |
Madrid, Spain, 08035 | |
MD Anderson Cancer Center Unidad de Investigación Clínica | |
Madrid, Spain, 28033 | |
H. Ramón y Cajal Servicio de Oncología Médica | |
Madrid, Spain, 28034 | |
H. Clínico de Valencia Servicio de Hematología y oncología Médica | |
Valencia, Spain, 46010 | |
United Kingdom | |
Western General Hospital Edinburgh Cancer Centre | |
Edinburgh, United Kingdom, EH4 2XU | |
Royal Marsden Hospital | |
London, United Kingdom, SW3 6JJ | |
The Royal Marsden NHS Trust Dpt of Medicine-Oncology | |
London, United Kingdom, SW3 6JJ | |
Nottingham University Hospitals NHS Trust Department of Clinical Oncology | |
Nottingham, United Kingdom, NG5 1PB |
Study Chair: | Fabrice André, MD | Institut Gustave Roussy, France | |
Study Chair: | Javier Cortes, MD | Hospital Universitario Vall d'Hebrón, Spain |
Additional Information:
Responsible Party: | Servier |
ClinicalTrials.gov Identifier: | NCT02053636 History of Changes |
Other Study ID Numbers: |
CL2-80881-001 2013-000288-10 ( EudraCT Number ) BIG 2-13 ( Other Identifier: BIG ) |
First Posted: | February 4, 2014 Key Record Dates |
Last Update Posted: | April 26, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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:
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Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | After Marketing Authorisation in EEA or US if the study is used for the approval. |
Access Criteria: | 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. |
URL: | http://clinicaltrials.servier.com |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |