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

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• 作者：Giandomenico Roviello¹ ; Manuela Milani² ; Angela Gobbi² ; Maria Rosa Cappelletti² ; Laura Zanotti² ; Chiara Senti² ; Alberto Bottini² ; Carla Strina² ; Sandra Sigala¹ ; Daniele Generali³ ; ^{daniele.generali@gmail.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Basal like ; Chemotherapy ; Combination treatment ; mtor inhibitor ; Taxane
• 刊名：Clinical Breast Cancer
• 出版年：2016
• 出版时间：June 2016
• 年：2016
• 卷：16
• 期：3
• 页码：e57-e59
• 全文大小：118 K

文摘

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.