Di Cosimo, Serena
Porcu, Luca
Agbor-tarh, Dominique
Cinieri, Saverio
Franzoi, Maria Alice
De Santis, Maria Carmen
Saura, Cristina
Huober, Jens
Fumagalli, Debora
Izquierdo, Miguel
Piccart, Martine
Daidone, Maria Grazia
de Azambuja, Evandro
Funding for this research was provided by:
GlaxoSmithKline (The NeoALTTO study was sponsored by GlaxoSmithKline from its inception until November 30, 2015, and by Novartis since then. Lapatinib is an asset of Novartis AG as of March 2, 2015. Funding sources had no involvement in study design, data collection, analysis and interpretation, writing of the report, and decision to submit the article for publication.)
Article History
Received: 10 July 2020
Accepted: 13 October 2020
First Online: 27 October 2020
Ethics approval and consent to participate
: The NeoALTTO trial (Breast International Group 01-06) is a randomized, multicenter, open-label, phase 3 study. From Jan 5, 2008, to May 27, 2010, 455 patients entered the study from 86 sites in 23 countries in Europe, Asia, North and South America, and South Africa. The ethics committee and relevant health authorities at each participating institution approved the study protocol. All women gave written informed consent before study entry.Patients’ participation in this sub-study was allowed after signing the main study consent form, which included a non-specific clause for use of clinical data for secondary analyses.
: This manuscript does not include any individual person’s details, so patient consent for publication is not applicable in this case. All authors listed and the NeoALTTO steering committee approved the present manuscript and consented for its publication.
: SDC reports honoraria and advisory board from Novartis and Pierre-Fabre outside the scope of this work. DF received support for his Institution from GlaxoSmithKline until November 30, 2015, and from Novartis since then for the conduction of the NeoALTTO study, from AstraZeneca, Pfizer, Roche/Genentech, Servier, and Tesaro outside the submitted work. EdA reports honoraria and advisory board from Roche/GNE, Novartis, and Seattle Genetics; travel grants from Roche/GNE and GSK/Novartis; and research grant to his institution from Roche/GNE, Astra-Zeneca, GSK/Novartis, and Servier. CS, MAF, LP, DAT, SC, MCS, and MGD have no conflicts of interest to declare. HJ received honoraria from Roche, Novartis; advisory board from Roche, Novartis; and travel support from Roche, Novartis. MI is an employee of Novartis and has stock or other ownership: Novartis. MP declared the following: Board Member (Scientific Board): Oncolytics, Radius; Consultant (honoraria): AstraZeneca, Camel-IDS, Crescendo Biologics, Debiopharm, G1 Therapeutics, Genentech, Huya, Immunomedics, Lilly, Menarini, MSD, Novartis, Odonate, Oncolytics, Periphagen, Pfizer, Roche, Seattle Genetics; research grants to her institute: AstraZeneca, Lilly, MSD, Novartis, Pfizer, Radius, Roche-Genentech, Servier, Synthon; MGD has no conflicts of interest to declare.