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. PATIENTS AND 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. CONCLUSION: 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

A Phase Ib Open-Label Study to Assess the Safety and Tolerability of Everolimus in Combination with Eribulin in Triple-Negative Breast Cancers / ROVIELLO, Giandomenico; Milani, Manuela; Gobbi, Angela; Cappelletti, Maria Rosa; ZANOTTI, Laura; Senti, Chiara; BOTTINI, Alberto; STRINA, CARLA; SIGALA, Sandra; GENERALI, Daniele. - In: CLINICAL BREAST CANCER. - ISSN 1526-8209. - ELETTRONICO. - 16:(2016), pp. e57-e59. [10.1016/j.clbc.2016.02.012]

A Phase Ib Open-Label Study to Assess the Safety and Tolerability of Everolimus in Combination with Eribulin in Triple-Negative Breast Cancers

ROVIELLO, Giandomenico;
2016

Abstract

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. PATIENTS AND 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. CONCLUSION: 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
2016
16
e57
e59
ROVIELLO, Giandomenico; Milani, Manuela; Gobbi, Angela; Cappelletti, Maria Rosa; ZANOTTI, Laura; Senti, Chiara; BOTTINI, Alberto; STRINA, CARLA; SIGAL...espandi
File in questo prodotto:
File Dimensione Formato  
1-s2.0-S1526820916300325-main.pdf

Accesso chiuso

Dimensione 118.87 kB
Formato Adobe PDF
118.87 kB Adobe PDF   Richiedi una copia

I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1156811
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 5
  • ???jsp.display-item.citation.isi??? 4
social impact