BIG 2-13


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An open, 3-cohort, phase II trial testing oral administration of lucitanib in patients with FGFR1-amplified or non-amplIfied oestrogeN rEceptor poSitive metaStatic breast cancer

FINESSE was set up to evaluate the efficacy of lucitanib in patients with FGFR1-amplified or non-amplified oestrogen receptor-positive (ER+) metastatic breast cancer, i.e. to assess if this drug had the potential to slow down or stop the growth of breast cancer tumours that no longer responded to standard treatments. Another purpose of the study was to collect information regarding the tolerability and side effects of the drug.

Lucitanib is an inhibitor of angiogenesis (i.e. it blocks the formation and growth of new blood vessels, which tumours need to grow) and FGFR (Fibroblast Growth Factor Receptor) proteins. It is a targeted agent that inhibits/blocks the action of the FGFR1 protein, which plays a role in cancer progression.

Tumour cells with amplified FGFR1 genes/proteins are often associated with poor prognosis. Amplification of genes/proteins on the chromosomal arm 11q might also affect the efficacy of the drug.

Phase I studies on human beings showed that lucitanib  ̶  when administered at the recommended dose of 10 mg daily  ̶  had an acceptable safety profile.

The main objective of FINESSE was to evaluate the effects of lucitanib and the response rate in patients with metastatic breast cancer whose tumours harboured abnormalities in the FGFR1 and/or chromosome arm 11q genes/proteins, i.e. either amplified or non-amplified cancer cells. In particular, the trial aimed to determine whether this drug had the potential to slow down or stop such cancer cells from growing or spreading further.

The secondary objectives were to determine the clinical benefit rate and progression-free survival (PFS), as well as to evaluate the drug’s safety.

Recruitment in the study was stopped prematurely as the drug was associated with less tolerability and more safety concerns than predicted. Additionally, lucitanib was not shown to be better for patients than available standard chemotherapy.

Still, the study data suggest that lucitanib might provide antitumour activity in patients with hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer. Exploratory biomarker analyses also show that patients with high FGFR1 amplification present a higher objective response rate (ORR) (25%) than those without amplification (8%). Investigators therefore hypothesise that patients with high FGFR1 expression might derive more benefit from lucitanib and recommend to further explore this patient population in a large trial.

FINESSE was a single arm study: all patients enrolled in the trial received lucitanib.

Patients were divided into 3 groups (cohorts), depending on the molecular characterisation of their tumour:

  • cohort 1 = FGFR1-amplified
  • cohort 2 = FGFR1-non-amplified with 11q amplification
  • cohort 3 = FGFR1-non-amplified without 11q amplification.

FINESSE involved 76 patients with FGFR1-amplified or non-amplified oestrogen receptor-positive metastatic breast cancer, and whose tumours no longer responded to standard treatments. 

Coordinating partners: Breast International Group (BIG), Institut Jules Bordet’s Clinical Trials Support Unit (IJB-CTSU) (formerly BrEAST) and Frontier Science & Technology Research Foundation (FSTRF).

Pharmaceutical partner and sponsor: Servier

The study started in June 2013, but the recruitment was stopped prematurely (end of 2016) after the inclusion of 76 patients. This was done because the drug was associated with less tolerability and more safety concerns than predicted and because it did not show a benefit to patients that was better than available standard chemotherapy treatments in other clinical trials.

The data collected in FINESSE are currently being analysed and a Clinical Study Report will be issued.

The study involved 24 hospitals based in 9 different countries: Australia, Belgium, Canada, France, Germany, Hungary, Italy, Spain, and UK.

FINESSE was funded by the Institut de Recherches Internationales Servier (I.R.I.S.), a research-based pharmaceutical company based in France that produces the drug lucitanib used in this study.

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