title: A Phase Ib Open-Label Study to Assess the Safety and Tolerability of Everolimus in Combination With Eribulin in Triple-Negative Breast Cancers.
abstract: BACKGROUND
  The VERITAS (A Phase 1B open-label study to assess the safety and tolerability of everolimus in combination with eribulin in triple-negative breast cancers) trial (EudraCT number: 2014-000135-17) is a phase Ib, open label, multicenter, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study based on the combination of everolimus with eribulin in sequential cohorts of metastatic triple negative breast cancer (TNBC) patients.
  
  
  METHODS
  The primary objective of the study is to identify the recommended dose of everolimus in combination with eribulin. Secondary endpoints include the assessment of pharmacokinetics and antitumor activity of the experimental treatment. The sample size is based on the Bayesisan approach with regards to the maximum tolerated dose (MTD) and maximum tolerated dose (MTD) observed. An average sample size of approximately 12 patients is deemed reasonable based on simulations.
  
  
  CONCLUSIONS
  The VERITAS trial is expected to determine the recommended dose of everolimus in combination with eribulin in TBNC. This study may open the way for further analysis of this combination in phase II studies in this orphan disease of active drug combination such as the TNBC subset.
authors.affiliation: Section of Pharmacology and University Center DIFF-Drug Innovation Forward Future, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
authors.forename: Giandomenico
authors.initials: G
authors.lastname: Roviello
authors.affiliation: U.S. Terapia Molecolare e Farmacogenomica, AO Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Manuela
authors.initials: M
authors.lastname: Milani
authors.affiliation: U.S. Terapia Molecolare e Farmacogenomica, AO Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Gobbi
authors.affiliation: U.S. Terapia Molecolare e Farmacogenomica, AO Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Cappelletti
authors.affiliation: U.S. Terapia Molecolare e Farmacogenomica, AO Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Zanotti
authors.affiliation: U.S. Terapia Molecolare e Farmacogenomica, AO Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Senti
authors.affiliation: U.S. Terapia Molecolare e Farmacogenomica, AO Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Bottini
authors.affiliation: U.S. Terapia Molecolare e Farmacogenomica, AO Azienda Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Strina
authors.affiliation: Section of Pharmacology and University Center DIFF-Drug Innovation Forward Future, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
authors.forename: Sandra
authors.initials: S
authors.lastname: Sigala
authors.affiliation: Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy. Electronic address: daniele.generali@gmail.com.
authors.forename: Daniele
authors.initials: D
authors.lastname: Generali
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D005260:Female; D005663:Furans / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D006801:Humans; D007659:Ketones / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D012107:Research Design; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy*; D000095662:Polyether Polyketides
chemical_list: D000068338:Everolimus; D005663:Furans; D007659:Ketones; C490954:eribulin; D000095662:Polyether Polyketides
keywords: Basal like; Chemotherapy; Combination treatment; Taxane; mtor inhibitor