Document is current

Article History

Received: 26 September 2022

Accepted: 3 November 2022

First Online: 23 January 2023

Declarations

:

: LV is a parttime employee of Agendia; and holds stock options from this employment. ASC reports grants and institutional research funding from Novartis and Lilly; and reports an uncompensated position on the Scientific Steering Committee for Novartis. AJC reports grants and institutional research funding from Merck, Amgen, Puma and SeaGen. ML reports grants and institutional research funding from Eisai, Exact Sciences, Genentech, Genomic Health, GRAIL, Menarini Silicon Biosystems, Merck, Novartis, Seattle Genetics, and Tesaro; reports travel support from AstraZeneca, Genomic Health, and Ionis; reports institutional support for Advisory Boards from AstraZeneca, Celgene, Roche/Genentech, Genomic Health, GRAIL, Ionis, Merck, Pfizer, Seattle Genetics, Syndax; became an employee of Natera in 2022; and holds stock options from this employment. HH reports institutional research funding from Arvinas, Abbvie, Celcuity, GSK, G1 therapeutics, Quantum Leap Healthcare Collaborative, Pfizer, and Zymeworks; reports participation on Advisory Boards for Novartis, AstraZeneca and Gilead; and received a grant from the Department of Defense. CY reports grants and institutional research funding from the National Cancer Institute, and Quantum Leap Healthcare Collaborative; and received travel reimbursement from Quantum Leap Healthcare Collaborative. JP reports participation on a Data Safety Monitoring Board for QuantumLEAD; reports participation on an Advisory Board for VIVLI, University of Wisconsin SPORE, and a reviewer for PCORI; received travel reimbursement for ASCO and SABCS; served as an ISPY Trial Advocate Lead; and serves as a faculty member for Methods in Clinical Research. EC reports institutional research funding from Oncocyte, C2i Genomics, the Parker Institute, UHG, ChipDX, Tempus, Merck, Becton Dickinson, Menarini/Janssen, and AstraZeneca; reports honoraria from AstraZeneca, GuardantHealth, and BMS; and received research support from Personalis. LE is an unpaid member of the Board of Directors for Quantum Leap Healthcare Collaborative; reports institutional research funding from Quantum Leap Healthcare Collaborative, Merck, and the National Cancer Institute (P-01); serves on the Blue Cross Medical Advisory Panel, and receives reimbursement for travel, and honorarium for her participation. JP reports honoraria from Roche, Gilead, AstraZeneca, and Daiichi Sankyo. LAC has served as an expert consultant for Teva Pharmaceuticals, Eisai, Sanofi, Lilly, Imerys, Colgate, Whittaker, Clark and Daniels, and Sterigenics in litigation. AD reports institutional research funding from Pfizer, Genentech, Novartis, Inivata, and Calithera; reports unpaid leadership roles for American Society of Clinical Oncology, AACR San Antonio Breast Cancer Symposium, and ECOG/ACRIN Cooperative Group; received honorarium from the NCI Breast Cancer Steering Committee; and reports participation on a Data Safety Monitoring Board for QuantumLEAD; reports participation on an Advisory Board for VIVLI, University of Wisconsin SPORE, and a reviewer for PCORI. All other participating authors have no disclosures to report. The rest of the authors declare no competing interests.

: The I-SPY 2 Trial sites that participated in the SURMOUNT sub-study obtained Institutional Review Board approval at each site.

: All patients provided written informed consent to the sub-study.

: Not Applicable.