Sponsorship and article processing charges for this study were funded by Novartis. We thank the patients who participated in the BOLERO-2 trial and the investigators, study nurses, and clinical research associates from the individual trial centers who provided ongoing support. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. We thank Jerome F Sah, PhD, ProEd Communications, Inc., for his medical editorial assistance with this manuscript. Dr. Denise A. Yardley is the guarantor for this article, and takes responsibility for the integrity of the work as a whole.
Conflict of interest
Wentao Feng is an employee of Novartis.
Ayelet Cahana is an employee of Novartis.
Tetiana Taran is an employee of Novartis.
David Lebwohl is an employee of Novartis.
Francis P. Arena has been a consultant/advisor for Novartis and has received research funding from Novartis.
José Baselga has been a consultant/advisor for Novartis.
Mario Campone has been a consultant/advisor for Novartis, has received honoraria from Novartis, and has received research funding from Novartis.
Frans Erdkamp has been a consultant/advisor for Amgen, Roche, Novartis, and Sanofi-Aventis.
Michael Gnant has been a consultant/advisor for Novartis and Herrion, has received honoraria from Amgen, Pfizer, Novartis, GlaxoSmithKline, Bayer, Sandoz, AstraZeneca, and Genomic Health, and has received research funding from GlaxoSmithKline, Sanofi-Aventis, and Roche.
Gabriel N. Hortobagyi has been a consultant/advisor for Allergan, Amgen, Antigen Express, AstraZeneca, Galena, Genentech, Novartis, Rockpointe, and Taivex, and has received research funding from Novartis.
Bohuslav Melichar has been a consultant/advisor for Roche and Novartis, has received honoraria from Amgen, Pfizer, GlaxoSmithKline, and has received other forms of remuneration from Novartis and Roche.
Shinzaburo Noguchi has been a consultant/advisor for Novartis, has received honoraria from Novartis, and has received research funding from Novartis and Pfizer.
Kathleen I. Pritchard has been a consultant/advisor for, received honoraria from, and provided expert testimony for Novartis, GlaxoSmithKline, Boehringer-Ingelheim, Amgen, AstraZeneca, Roche, Bristol-Myers Squibb, Sanofi-Aventis, and Pfizer.
Denise A. Yardley has been a consultant/advisor for Novartis.
Martine Piccart has been a consultant/advisor for Novartis.
Barbara Pistilli has been a consultant/advisor for Novartis Oncology.
Wael A. Harb has received research funding from Horizon Oncology Research.
Hope S. Rugo has received research funding and other forms of remuneration from Novartis.
Howard A. Burris III and Katarina Petrakova declare that they have no conflicts of interest.
Compliance with ethical guidelines
This study was in accordance with the ethical standards of the institutional review board at each participating center and the study was conducted in accordance with the principles of Good Clinical Practice, the provisions of the Declaration of Helsinki of 1975, as revised in 2000 and 2008, and other applicable local regulations. Written informed consent was obtained from all patients before enrollment.
Open Access
This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.