Lucitanib for the treatment of HRþ/HER2- Metastatic breast cancer: Results from the multicohort phase II FINESSE study: Clinical Cancer Research

R. Hui, A. Pearson, J. Cortes, C. Campbell, C. Poirot, Jr. Azim H.A., D. Fumagalli, M. Lambertini, F. Daly, A. Arahmani, J. Perez-Garcia, P. Aftimos, P.L. Bedard, L. Xuereb, E.D. Scheepers, M. Vicente, T. Goulioti, S. Loibl, S. Loi, M.-J. PierratN.C. Turner, F. Andre, G. Curigliano

Research output: Contribution to journalArticlepeer-review


Purpose: The FGFR1 gene is amplified in 14% of patients with HRþ/HER2- breast cancer. Efficacy and safety of lucitanib, an inhibitor of VEGFR1-3, FGFR1-3, and PDGFRa/b, were assessed. Patients and Methods: Patients with HRþ/HER2- metastatic breast cancer (MBC) received oral lucitanib in three centrally confirmed cohorts: (i) FGFR1 amplified, (ii) FGFR1 nonamplified, 11q13 amplified, and (iii) FGFR1 and 11q13 nonamplified. Key inclusion criteria included Eastern Cooperative Oncology Group Performance Status ≤2, ≥1 line of anticancer therapy, but ≤2 lines of chemotherapy. Primary endpoint was overall response rates (ORR) by RECIST1.1. Simon's two-stage design was used: If ≥2 patients responded among 21 patients, 20 additional patients could be enrolled in each cohort. FGFR1 copy-number variation (CNV) was determined by FISH and droplet digital PCR, whereas FGFR1 expression was determined by IHC. Results: Seventy-six patients (32/18/26 in cohorts 1/2/3) from nine countries were enrolled. The prespecified primary endpoint was met in cohort 1 with ORR of 19% [95% confidence interval (CI), 9%–35%], but not in cohorts 2 and 3 with ORR of 0% (95% CI, 0%–18%) and 15% (95% CI, 6%–34%), respectively. Frequent adverse events included hypertension (87%), hypothyroidism (45%), nausea (33%), and proteinuria (32%). Exploratory biomarker analyses suggested higher ORR in patients with high FGFR1 amplification (≥4 CNV) than those without high amplification (22% vs. 9%). ORR in patients with FGFR1-high tumors (IHC, H-score ≥50) was 25% versus 8% in FGFR1-low cancers. Conclusions: Lucitanib had modest antitumor activity and significant hypertension-related toxicity in patients with HRþ/ HER2- MBC. Although based on small sample sizes, exploratory biomarker analyses suggested that patients with high FGFR1 amplification or expression might derive greater benefit. © 2020 American Association for Cancer Research.
Original languageEnglish
Pages (from-to)354-363
Number of pages10
JournalClin. Cancer Res.
Issue number2
Publication statusPublished - 2020


  • biological marker
  • fibroblast growth factor 23
  • fibroblast growth factor receptor 1
  • lucitanib
  • abdominal pain
  • adult
  • aged
  • antineoplastic activity
  • Article
  • asthenia
  • cancer chemotherapy
  • cohort analysis
  • controlled study
  • copy number variation
  • diarrhea
  • droplet digital polymerase chain reaction
  • drug dose reduction
  • drug efficacy
  • drug safety
  • drug withdrawal
  • fatigue
  • female
  • FGFR1 gene
  • fluorescence in situ hybridization
  • gene amplification
  • gene expression
  • headache
  • human
  • human cell
  • human epidermal growth factor receptor 2 negative breast cancer
  • human tissue
  • hypertension
  • hypothyroidism
  • immunohistochemistry
  • loss of appetite
  • major clinical study
  • metastatic breast cancer
  • monotherapy
  • multicenter study
  • multiple cycle treatment
  • myalgia
  • nausea
  • open study
  • phase 2 clinical trial
  • priority journal
  • proteinuria
  • response evaluation criteria in solid tumors
  • thrombocytopenia
  • treatment response
  • vomiting


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