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Article History

Received: 14 September 2023

Accepted: 18 January 2024

First Online: 31 January 2024

Declarations

:

: This study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice Standards and the Declaration of Helsinki. The trial was conducted through the Translational Breast Cancer Research Consortium. Institutional review board approval was obtained at Dana-Farber/Harvard Cancer Center and at all participating sites. Monitoring of trial progress and safety was reviewed twice-yearly by the DF/HCC independent data safety monitoring board (DSMB). All patients provided written informed consent prior to initiating any study treatments or procedures.

: Not applicable.

: The authors declare competing financial interests: F.L. reports consulting for Astra-Zeneca, Pfizer and ION, and receiving research support to the institution from Astra-Zeneca, CytomX, Daiichi Sankyo, Eisai and Incyte. L.E.S. is current employee of Astra-Zeneca, Waltham, MA. K.P. serves on the Scientific Advisory Board of Novartis, Ideaya Biosciences, and Scorpion Therapeutics, holds equity in Scorpion Therapeutics and Ideaya Biosciences, is a consultant to Redona Therapeutics, and receives research support through DFCI from Novartis. M.M.R. receives research support from Novartis, Pfizer, Ipsen, TerSera, Roche, AstraZeneca, Bristol-Myers Squibb, Bayer, and consulting or advisory role for Bristol-Myers Squibb, Tolmar, AstraZeneca, TerSera. A.S.C. serves on a scientific advisory board for Novartis and reports institutional research support from Novartis and Lilly as well as honoraria from Siemens. N.U. is a consultant for AstraZeneca plc, Bayer AG, Pfizer Inc., Gilead Sciences, Inc., Chugai Pharmaceutical Co., CytoDyn Inc., Daiichi Sankyo, Inc., DynaMed, LLC, Eisai Co., Ltd., KeChow Pharma, Inc., Lavender Health Ltd., OBI Pharma Inc., OncoCyte Co., Ourotech, Inc., DBA Pear Bio, Kirilys Therapeutics, Inc., Peptilogics, Inc., Phoenix Molecular Designs, Preferred Medicine, Inc., Puma Biotechnology, Inc., Sumitomo Dainippon Pharma, Inc., Sysmex Co. Ltd., Takeda Pharmaceuticals, Ltd., Unitech Medical, Inc., CARNA Biosciences, Inc., ChemDiv, Inc., DualityBio, LARVOL, Oncolys BioPharma Inc., Rakuten Medical, Inc., Merck Co., AnHeart Therapeutics Inc., Carisma Therapeutics, Inc., and Therimunex; has research agreements with AnHeart Therapeutics Inc., Eisai Co., Ltd., Gilead Sciences, Inc., Phoenix Molecular Designs, Daiichi Sankyo, Inc., Puma Biotechnology, Inc., Merck Co., Oncolys BioPharma Inc., OBI Pharma Inc., ChemDiv, Inc., Tolero Pharmaceuticals, Inc., and VITRAC Therapeutics, LLC, and has speaker or preceptorship roles with Bristol-Myers Squibb, CareNet Inc, Chugai Pharmaceutical Co., Genomic Health, Kyowa Hakko Kirin Co., Ltd., Sumitomo Dainippon Pharma, Inc., and Medscape. E.T.R. is a current employee of Merck & Co., Inc., Boston, MA, and has received institutional research support from AstraZeneca. I.E.K. reports consulting or advisory role for Daiichi/Sankyo, AstraZeneca, Macrogenics, Genentech/Roche, and Seagen, serves on Data Monitoring Board for Novartis and Merck, receives research support to the institution from Pfizer and Genetic/Roche and his spouse is a current employee and had equity in PureTech Health. S.M.T. reports consulting/advisory role for Novartis, Pfizer, Merck, Eli Lilly, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squibb, Seattle Genetics, CytomX Therapeutics, Daiichi Sankyo, Gilead, Ellipses Pharma, 4D Pharma, OncoSec Medical Inc., BeyondSpring Pharmaceuticals, OncXerna, Zymeworks, Zentalis, Blueprint Medicines, Reveal Genomics, ARC Therapeutics, Infinity Therapeutics, Zetagen, Myovant, Umoja Biopharma, Artios Pharma, Menarini/Stemline, Aadi Biopharma, Bayer, Incyte Corp., and Jazz Pharmaceuticals; and research funding from Genentech/Roche, Merck, Exelixis, Pfizer, Lilly, Novartis, Bristol Myers Squibb, Eisai, AstraZeneca, NanoString Technologies, Gilead, Seattle Genetics, and OncoPep. V.S. received research grants to institution from Abbvie, Biocept, Novartis, Pfizer, Puma Biotechnology, and QUE Oncology, served on the advisory board of Novartis 10/25/2021, and Chair of the AstraZeneca Data Safety Monitoring Board, non-financial support: Foundation Medicine Study Assays. G.P.G. holds equity in Naveris, Inc, and has received research funding from Breakpoint Therapeutics and Merck & Co. T.C.H. receives research grant funding to Mayo Clinic from Takeda Oncology and consulting fees given to Mayo Clinic from Puma Biotechnology. E.A.M. reports compensated service on scientific advisory boards for Astra Zeneca, BioNTech and Merck; uncompensated service on steering committees for Bristol Myers Squibb and Roche/Genentech; speakers honoraria and travel support from Merck Sharp & Dohme; and institutional research support from Roche/Genentech (via SU2C grant) and Gilead. E.A.M. also reports research funding from Susan G. Komen for the Cure for which she serves as a Scientific Advisor, and uncompensated participation as a member of the American Society of Clinical Oncology Board of Directors. J.R.B. received royalties from Wolters Kluwer, and honoraria from Oncoclinicas and MJH life, and she is a speaker for Varian. J.B. receives research support from Genentech/Roche and Incyte Corporation, has received advisory board payments from AstraZeneca and Mallinckrodt, and is an inventor on patents regarding immunotherapy targets and biomarkers in cancer. T.K. is a member of the Scientific advisory board of Exact Sciences and received speakers’ honoraria from Exact Sciences. All other authors declare no potential conflicts of interest.