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Article History

Received: 24 April 2025

Accepted: 12 June 2025

First Online: 23 June 2025

Declarations

:

: The study was approved by Institutional Review Boards at each participating clinical site, and a Data Safety Monitoring Board met monthly to review patient safety and study progress. The I-SPY2.2 trial complies with all local and national regulations regarding the inclusion of human study participants and was conducted in accordance to the criteria set by the Declaration of Helsinki. All participants in the study provided written informed consent. The authors of this manuscript vouch for the accuracy and completeness of the data reported.

: Not applicable.

: RLF reports providing consulting services for Gilead Sciences, AstraZeneca, Lyell Immunopharma, and Merck, outside the scope of this work, with fees paid to his institution (no personal payments); reports personal honoraria from MJH Life Sciences for CME events, and Connected Research and Consulting for consulting activities. CY reports institutional research grant from NCI/NIH; salary support and travel reimbursement from Quantum Leap Healthcare Collaborative; US patent titled, “Breast cancer response prediction subtypes,” (No. 18/174,491); and University of California Inventor Share. KVG reports participation in Advisory Board with honoraria to institution for AstraZeneca, Novartis, Puma Biotechnologies, Eli Lilly, Gilead, Exact Sciences, Neogenomics and Tersera Therapeutics. RM reports research stipend from GE Healthcare. NMH reports institutional research funding from NIH. WFS reports shares of IONIS Pharmaceuticals and Eiger Biopharmaceuticals; received consulting fees from AstraZeneca; is a cofounder with equity in Delphi Diagnostics; issued patents for: (1) a method to calculate residual cancer burden, and (2) genomic signature to measure sensitivity to endocrine therapy. MPG is the Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D. and reports personal fees for CME activities from AXIS, BroadcastMed, DAVA Oncology, IDEOlogy Health, MJH Life Sciences, PeerView, Physicians’ Education Resource, Research to Practice, Total Health Conferencing; consulting fees to Mayo Clinic from AstraZeneca Pharmaceuticals LP, AstraZeneca UK Ltd., BeiGene USA, Biotheranostics, Biotheryx, eChinaHealth, EcoR1, Eli Lilly and Company, Engage Health Media, Genentech, Lilly, Laekna, Stemline Therapeutics, MJH Life Sciences, Novartis, Puma Biotechnology, RNA Diagnostics, Seattle Genetics, Sermonix Pharmaceuticals, TerSera Therapeutics/Amplity Health; grant funding to Mayo Clinic from AstraZeneca, ATOSSA Therapeutics, Biotheryx, Lilly, Loxo, Pfizer, Sermonix, SimBioSys; travel support from Lilly. JCB receives funding paid to her institution from Eli Lilly and SymBioSis and sits on the Data Safety Monitoring Committee of CairnsSurgical. She has received honoraria from PER, PeerView, OncLive, EndoMag and Up-To-Date. ADM reports institutional research funding from Novartis, Pfizer, Genentech and Neogenomics; Program Chair, Scientific Advisory Committee, ASCO. DY reports research funding from NIH/NCI P30 CA 077598, P01 CA234228-01 and R01CA251600; consulting fees from Martell Diagnostics; and honoraria and travel for speaking at the “International Breast Cancer Conference.” LJvV is a founding advisor and shareholder of Exai BIo; part-time employee and owns stock in Agendia. HSR reports institutional research support from AstraZeneca, Daiichi Sankyo, Inc., F. Hoffmann-La Roche AG/Genentech, Inc., Gilead Sciences, Inc., Lilly; Merck & Co., Novartis Pharmaceuticals Corporation, Pfizer, Stemline Therapeutics, OBI Pharma, Ambrx, Greenwich Pharma; advisory and consulting roles with Chugai, Puma, Sanofi, Napo, and Mylan. LJE reports funding from Merck & Co.; participation on an advisory board for Blue Cross Blue Shield; and personal fees from UpToDate; unpaid board member of QLHC. All other authors declare no competing interests.