Schettini, Francesco
Sobhani, Navid
Ianza, Anna
Triulzi, Tiziana
Molteni, Alfredo
Lazzari, Maria Chiara
Strina, Carla
Milani, Manuela
Corona, Silvia Paola
Sirico, Marianna
Bernocchi, Ottavia
Giudici, Fabiola
Cappelletti, Maria Rosaria
Ciruelos, Eva
Jerusalem, Guy
Loi, Sherine
Fox, Stephen B.
Generali, Daniele https://orcid.org/0000-0001-6002-1530
Funding for this research was provided by:
Novartis Pharmaceuticals UK Limited
MEDnoTE srl
Article History
Received: 19 June 2020
Accepted: 31 July 2020
First Online: 7 August 2020
Compliance with ethical standards
:
: The funders had no role in the design of the study, nor in the collection, analysis, and interpretation of the data, writing of the manuscript, and the decision to submit the manuscript for publication. Francesco Schettini has declared travel and accommodation expenses paid by Pfizer and Celgene. Guy Jerusalem has reported grants, personal fees and non-financial support from Novartis, grants, personal fees and non-financial support from Roche, grants, personal fees and non-financial support from Pfizer, personal fees and non-financial support from Lilly, personal fees from Celgene, personal fees and non-financial support from Amgen, personal fees and non-financial support from BMS, personal fees from Puma Technology, personal fees and non-financial support from Astra-Zeneca, personal fees from Daiichi Sankyo, personal fees from Abbvie, outside the submitted work. DG has declared consulting fees from Novartis, Lilly and Pfizer, research funding from LILT, Novartis Astra-Zeneca and University of Trieste. Sherine Loi’s and Stephen B Fox’s institution receives research funding from Bristol-Myers Squibb, Eli Lilly, Genentech, Merck, Novartis, Pfizer, Puma Biotechnology and Roche. Sherine Loi has acted as a non-compensated consultant of Astra-Zeneca, Bristol-Meyers Squibb, Merck, Novartis, Pfizer, Roche-Genentech and Seattle Genetics. All other authors declared no conflict of interest.
: The MREC study received the ethical approval from the UK Northern and Yorkshire MREC (MREC Reference 04/MRE03/89) and all patients gave their informed consent to participate. The mTOR study was approved by the Ethical Committee Val Padana-Cremona (IRB Code: 12063/2015) and patients provided informed written consent to participate. In the BALLET trial informed consent was formally obtained from all patients. The protocol was independently approved by the Ethical Committee review board at each site []. All these studies were conducted accordingly to Good Clinical Practice guidelines and in conformity with the 1964 Declaration of Helsinki and its later amendments.