O’Shaughnessy, Joyce http://orcid.org/0000-0001-6764-2807
Brufsky, Adam
Rugo, Hope S.
Tolaney, Sara M.
Punie, Kevin
Sardesai, Sagar
Hamilton, Erika
Loirat, Delphine
Traina, Tiffany
Leon-Ferre, Roberto
Hurvitz, Sara A.
Kalinsky, Kevin
Bardia, Aditya
Henry, Stephanie
Mayer, Ingrid
Zhu, Yanni
Phan, See
Cortés, Javier
Clinical trials referenced in this document:
Documents that mention this clinical trial
Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression
https://doi.org/10.1200/jco.23.01409
Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer
https://doi.org/10.1007/s10549-022-06602-7
Funding for this research was provided by:
Gilead Sciences, Inc.
Article History
Received: 2 December 2021
Accepted: 6 April 2022
First Online: 11 May 2022
Declarations
:
: Joyce O’Shaughnessy reports consultancy/advisory roles with AbbVie, Agendia, Amgen, Aptitude Health, AstraZeneca, Bristol Myers Squibb, Celgene, Eisai, G1 Therapeutics, Genentech/Roche, Gilead, Ipsen, Eli Lilly, Merck, Myriad, Novartis, Odonate, Pfizer, Puma, Prime Oncology, Seattle Genetics, and Syndax; honoraria from Gilead. Adam Brufsky reports consultancy roles with Pfizer, Gilead, Roche, Eli Lilly, Novartis, Eisai, Genentech, and Merck. Hope S. Rugo reports research funding from AstraZeneca, Pfizer, Novartis, Eli Lilly, Genentech, Gilead, MacroGenics, OBI, Merck, Gilead, Daiichi Sankyo, Seattle Genetics, Odonate, Ayala, Sanofi, and Sermonix; honoraria from Mylan, Samsung, and Puma. Sara M. Tolaney reports research funding from Bristol Myers Squibb, Eisai, Gilead, Genentech/Roche, Pfizer, Novartis, Nektar, Merck, AstraZeneca, Eli Lilly, and Exelixis. Kevin Punie reports research funding from Sanofi and MSD; consultancy/advisory roles with AstraZeneca, Eli Lilly, Gilead, Medscape, Novartis, Pfizer, Pierre Fabre, Roche, Roularta, and Vifor Pharma; honoraria from Eli Lilly, McCann Health, Mundi Pharma, MSD, Novartis, Pfizer, and Roche; travel/accommodations/expenses from AstraZeneca, Novartis, PharmaMar, Roche, and Pfizer. Sagar Sardesai reports consultancy roles with Gilead, Novartis, and Biotheranostics. Erika Hamilton reports institutional research funding from OncoMed, Genentech/Roche, Zymeworks, Rgenix, ArQule, Clovis, Silverback Therapeutics, Millenium, Acerta Pharma, Sermonix Pharmaceuticals, Torque, Black Diamond, Karyopharm, Infinity Pharmaceuticals, Curis, Syndax, Novartis, Boehringer Ingelheim, Immunomedics, FujiFilm, Taiho, Deciphera, Fochon, Molecular Templates, Onconova Therapeutics, Dana Farber Cancer Hospital, Hutchinson MediPharma, MedImmune, SeaGen, Puma Biotechnology, Compugen, TapImmune, Lilly, Pfizer, H3 Biomedicine, Takeda, Merus, Regeneron, Arvinas, StemCentRx, Verastem, eFFECTOR Therapeutics, CytomX, InventisBio, Lycera, Mersana, Radius Health, AbbVie, Nucana, Leap Therapeutics, Zenith Epigenetics, Harpoon, Orinove, AstraZeneca, Tesaro, Macrogenics, EMD Serono, Daiichi Sankyo, Syros, Sutro, G1 Therapeutics, Merck, PharmaMar, Olema, Polyphor, Immunogen, Plexxicon, Amgen, Akesobio Australia, and Shattuck Labs; consultancy/advisory roles with Genentech/Roche, Boehringer Ingelheim, Novartis, Dantari, Eli Lilly, Merck, Puma, Silverback Therapeutics, CytomX, Pfizer, Mersana, Black Diamond, H3 Biomedicine, Daiichi Sankyo, AstraZeneca, Arvinas, Deciphera Pharmaceuticals, Eisai, and Seattle Genetics. Delphine Loirat reports consultancy/advisory roles with Novartis, MSD, and Roche. Tiffany Traina reports consultancy/advisory roles with Genentech/Roche, Pfizer, AstraZeneca, Merck, Puma, Advaxis, Celgene, Innocrin, Genomic Health, Bristol Myers Squibb, Athenex, Aduro, Halozyme, Daiichi Sankyo, Ionis, Seattle Genetics, and Gilead; institutional research funding from Eisai, Pfizer, Novartis, Innocrin, AstraZeneca, Astellas, Gilead, Genentech/Roche, Daiichi Sankyo, and Carrick. Roberto Leon-Ferre reports consultancy/advisory roles with AstraZeneca and Gilead; research funding from the National Center for Advancing Translational Science and the Mayo Clinic Breast Cancer SPORE Career Enhancement Program. Sara A. Hurvitz reports research funding from Ambrx, Amgen, Arvinas, Bayer, Daiichi Sankyo, Genentech/Roche, GSK, Gilead, Eli Lilly, Macrogenics, Novartis, Pfizer, OBI Pharma, Pieris, PUMA, Phoenix Molecular Designs, Radius, Sanofi, Seattle Genetics, and Dignitana; stock from NK Max; stock (spouse) from ROMTech and Ideal Implant. Kevin Kalinsky reports research funding from Gilead, Novartis, Incyte, Genentech, Eli Lilly, Pfizer, Calithera, Acetylon, Seattle Genetics, Amgen, Zeno, and CytomX Therapeutics; advisory roles with Gilead, AstraZeneca, and Genentech; consulting fees from Gilead, Pfizer, Eisai, Eli Lilly, Novartis, Amgen, and AstraZeneca, Genentech, Merck, Seattle Genetics, Cyclacel, and OncoSec; honoraria from Eli Lilly; travel/accommodations/expenses from Eli Lilly, Pfizer, and AstraZeneca; employment (spouse) with Array Biopharma, Pfizer, and Grail. Aditya Bardia reports research funding from Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Gilead, and Biotheranostics; personal fees from Pfizer, Novartis, Genentech, Merck, Radius Health, Gilead, Taiho, Sanofi, Daiichi Sankyo/AstraZeneca, Puma, Phillips, Eli Lilly, and Foundation Medicine. Stephanie Henry reports consultancy/advisory roles with AstraZeneca, BMS, Merck, Gilead, Novartis, MSD, and Sanofi; travel/accommodations/expenses from MSD, Novartis, and Roche. Ingrid Mayer reports consultancy/advisory roles with Novartis, Pfizer, Genentech, Eli Lilly, Puma, AbbVie, Gilead, Macrogenics, Seattle Genetics, AstraZeneca, GSK, Cyclacel, Blueprint; research funding from Pfizer and Genentech. Yanni Zhu and See Phan report employment with Gilead and may own stock or stock options. Javier Cortés reports consultancy/advisory roles with Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, GEMoaB, and Gilead; honoraria from Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck, and Daiichi Sankyo; institutional research funding from Roche, ARIAD Pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer, Eisai, Roche, Guardant Health, Merck, Pfizer, Piqur Therapeutics, Puma, Queen Mary University of London; stock, patents, and intellectual property with MedSIR; travel, accommodation, and expenses with Roche, Novartis, Eisai, Pfizer, and Daiichi Sankyo.
: The ASCENT trial was conducted and approved by each investigational site’s institutional review board/ethics committee prior to initiation, and in accordance with the Declaration of Helsinki, International Council for Harmonisation Guidelines for Good Clinical Practice, FDA Code of Federal Regulations, national and local drug and data protection laws, and other applicable regulatory requirements.
: All patients provided written informed consent prior to enrollment in the study.
: Not applicable.