De Laurentiis, Michelino http://orcid.org/0000-0001-9009-1572
Borstnar, Simona
Campone, Mario
Warner, Ellen
Bofill, Javier Salvador
Jacot, William
Dent, Susan
Martin, Miguel
Ring, Alistair
Cottu, Paul
Lu, Janice
Ciruelos, Eva
Azim, Hamdy A.
Chatterjee, Sanjoy
Zhou, Katie
Wu, Jiwen
Menon-Singh, Lakshmi
Zamagni, Claudio
Clinical trials referenced in this document:
Documents that mention this clinical trial
Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population
https://doi.org/10.1007/s10549-021-06334-0
Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial
https://doi.org/10.1007/s10549-022-06543-1
Funding for this research was provided by:
Novartis Pharmaceuticals Corporation
Article History
Received: 7 December 2020
Accepted: 14 July 2021
First Online: 19 August 2021
Change Date: 8 October 2021
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s10549-021-06374-6
Declarations
:
: Michelino De Laurentiis has received honoraria for consulting or advisory roles from Amgen, AstraZeneca, Celgene, Eisai, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, and Roche; Honoraria: Amgen, AstraZeneca, Celgene, Eisai, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, and Roche; honoraria for participation in speakers’ bureau from Novartis; research funding from Bristol-Myers Squibb, Daiichi Sankyo, Lilly, Novartis, MacroGenics, MSD, Pfizer, Puma Biotechnology, and Roche. Simona Borstnar has received honoraria for consulting or advisory roles from Amgen, AstraZeneca, Lilly, Novartis, Pfizer, and Roche; honoraria for participation in speakers’ bureaux from Amgen, Lilly, Krka, Novartis, Pfizer, and Roche. Mario Campone has received honoraria for consulting or advisory roles from AstraZeneca, Novartis, AbbVie, Sanofi, Lilly, Pfizer, Sandoz, Servier, Accord, and Pierre Fabre; honoraria from Novartis and Lilly; honoraria for participation in speakers’ bureaux from Novartis and Lilly; reimbursement for travel, accommodations, and expenses from Pfizer, Roche, and AstraZeneca. Ellen Warner has received reimbursement for travel, accommodations, or expenses from Novartis. Javier Salvador Bofill has received honoraria for consulting or advisory roles from Roche, Novartis, Pfizer, and MSD; honoraria for participation in speakers’ bureaux from Novartis and Roche; honoraria from Novartis, Pfizer, and Roche; reimbursement for travel, accommodations, or expenses from Roche, Novartis, and Pfizer. William Jacot has received honoraria for consulting or advisory roles from AstraZeneca, Eisai, Lilly France, MSD, Novartis, Pfizer, and Roche; research funding from AstraZeneca; reimbursement for travel, accommodations, or expenses from AstraZeneca, Chugai Pharma, Eisai, GlaxoSmithKline, and Lilly France. Susan Dent has received honoraria for consulting or advisory roles from Novartis, Pfizer, and Roche; honoraria from Eli Lilly, Novartis, and Roche; research funding from Hoffman La-Roche, Novartis, and Pfizer; reimbursement for travel, accommodations, or expenses from AstraZeneca. Miguel Martin has received honoraria for consulting or advisory roles from Amgen, AstraZeneca, Eli Lilly, Novartis, Pfizer, PharmaMar, Puma Biotechnology, Roche/Genentech, and Taiho Oncology; honoraria for participation in speakers’ bureaux from AstraZeneca, Amgen, Roche/Genentech, Novartis, and Pfizer; research funding from Roche and Novartis. Alistair Ring has received honoraria for consulting or advisory roles from Pfizer and Roche; honoraria from AstraZeneca, Lilly, Novartis, Pfizer, and Roche; research funding from AstraZeneca. Paul Cottu has received honoraria for consulting or advisory roles from Novartis and Pfizer; research funding from AstraZeneca, Genentech/Roche, Novartis, Pierre Fabre, and Pfizer; reimbursement for travel, accommodations, or expenses from AstraZeneca, NanoString Technologies, Novartis, Pfizer, and Roche. Janice Lu has received honoraria for consulting or advisory roles from Pfizer, Novartis, and Puma. Eva Ciruelos has received honoraria for consulting or advisory roles from Pfizer, Novartis, Lilly, and Roche; honoraria from Pfizer, Novartis, Lilly, and Roche; honoraria for participation in speakers’ bureaux from Pfizer, Novartis, Lilly, and Roche; reimbursement for travel, accommodations, or expenses from Pfizer and Roche. Hamdy A. Azim has received honoraria for consulting or advisory roles from ASZ, Bristol-Myers Squibb, Janssen, MSD, Novartis, Pfizer, Amgen, Lilly, and Roche; employment by Innate France (immediate family member); honoraria from Amgen, ASZ, Bristol-Myers Squibb, MSD, Novartis, Pfizer, and Roche; research funding from Pfizer. Sanjoy Chatterjee has received honoraria for consulting or advisory roles from Tata Medical Center. Katie Zhou is employed by Novartis. Jiwen Wu is employed by Novartis. Lakshmi Menon-Singh is employed by Novartis. Claudio Zamagni has received honoraria for consulting or advisory roles from AstraZeneca, Eisai, Novartis, Pfizer, PharmaMar, Pierre Fabre, and Roche; research funding from AbbVie, Array BioPharma, AstraZeneca, Celgene, Medivation, Morphotek, Novartis, Pfizer, Roche, and Roche/Genentech; reimbursement for travel, accommodations, or expenses from Celgene, Novartis, Pierre Fabre, and Roche.
: The study was designed, implemented, and reported in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonized Tripartite Guidelines for Good Clinical Practice, applicable local regulations, and the ethical principles laid down in the Declaration of Helsinki. The protocol and informed consent form were reviewed and approved by a properly constituted Institutional Review Board/Independent Ethics Committee/ Research Ethics Board before study commencement. A steering committee oversaw the trial conduct, as per the approved protocol. Representatives of the trial sponsor, Novartis Pharmaceuticals (East Hanover, NJ), collected and analyzed the data.
: Written informed consent was obtained from all patients.
: Not applicable.