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Article History

Received: 20 September 2022

Accepted: 12 March 2023

First Online: 8 April 2023

Declarations

:

: B.A.P. has received clinical research support awarded to her institution for unrelated work from Pfizer, Novartis, Glaxo Smith Kline, Genentech/Roche, and Oncternal Therapeutics Inc., received consulting fees from Dare Biosciences, had stock in Merck, and served on the San Diego Susan G. Komen Board of Directors. R.A.S. has received clinical research support awarded to her institution for unrelated work from Oncosec, Oncternal Therapeutics Inc., Phoenix Molecular Designs, Genentech/Roche, Cytomx, and OBI Pharmaceuticals; received consulting fees from the Dedham Group, Sorteria Precision Medicine Foundation, Inc., Oncosec, and Gilead; and received honoraria from San Antonio Breast Cancer Symposium, Johnson and Johnson, Total Health Conferencing, and Integrity Continuing Education. R.B.S. has received salary grant support to his institution from the sponsor of the I-SPY2 trial, Quantum Leap Healthcare Collaborative, has a pending patent Compositions and Methods for Detecting Cancer, Serial No. 13/007,23, has participated in a Cardinal Health Advisory Board, and has equity in Biosplice Therapeutics. G.L.H. and her spouse have stock in Moderna, Exact Sciences, Gilead, and Nanostring. L.B.-S. has received salary support from Quantum Leap Healthcare Collaborative for I-SPY2 operations and from the National Institutes of Health/National Cancer Institute (R01 CA255442 and P01 CA210961). L.J.E. has been an unpaid member of the Board of Directors of Quantum Leap Healthcare Collaborative (QLHC), received grant support from QLHC and from National Cancer Institute (P01) for the I-SPY2 Trial, served on an Advisory Panel for Blue Cross for which she was paid for travel and received an honorarium for her time, and receives grant support for a breast DCIS vaccine trial funded by Merck through the University of California San Francisco. L.J.v.V. has been a part-time employee and stockholder in Agendia N.V. C.Y. has received salary support to the institution from Quantum Leap Healthcare Collaborative and the National Cancer Institute. T.J.K. has received research funding for zilovertamab (previously cirmtuzumab) that was developed by T.J.K. in the T.J.K. laboratory and licensed by the University of California to Oncternal Therapeutics, Inc.; has stock options from Oncternal Therapeutics, Inc.; and has received travel funds and/or honoraria from Pharmacyclics/ AbbVie, Genentech/Roche, Janssen, Gilead, European Research Initiative on CLL (ERIC), Dava Oncology, iwNHL, NCCN CLL/ SLL Hairy Cell Leukemia Panel Meeting, Society of Hematologic Oncology. A.M.W., D.M.W., and E.M.G. have no conflicts to declare.

: Approval was obtained from Institutional Review Boards at all participant institutions covering the clinics where patients were enrolled in I-SPY2 protocol as previously reported. University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, Box 1710, San Francisco, CA 94143; University of California San Diego, 3855 Health Sciences Dr. M/C 0698, La Jolla, CA 92093; University of Alabama Birmingham (UAB), Birmingham Comprehensive Cancer Center, 1802 Sixth Avenue South 2510, North Pavilion, Birmingham, AL 35294–3300; University of Minnesota (UMinn), Masonic Cancer Center, 420 Delaware St., SE, MMC 480, Minneapolis, MN 55455; Swedish Cancer Institute (Swedish), 1221 Madison Street, Seattle, WA 98104; Loyola University Medical Center, Cardinal Bernardin Cancer Center, 2160 South First Ave, Room 109, Maywood, IL 60153; Mayo Clinic Rochester (Mayo MN), 200 First St, SW, Rochester, MN 55905; University of Pennsylvania (UPenn), MSCE 3 Perelman Center 3400 Civic Center Blvd, Philadelphia, PA 19104; University of Texas, MD Anderson (MDACC), Breast Medical Oncology Dept. – Unit 1354, 1515 Holcombe Blvd., Houston, TX 77030; Georgetown University (Gtown), Lombardi Cancer Center, 3800 Reservoir Rd, NW 2^nd Level Podium B, Washington, DC 20007; University of Chicago (UChi), 5841 S. Maryland Avenue, MC 2115, Chicago, IL 60437; University of Colorado (UCD), University of Colorado Cancer Center, 1665 Aurora Ct., Rm. 3200, MS F700, Aurora, CO 80045; Oregon Health and Science University, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239; University of Texas, Southwestern (UTSW), University of Texas, Southwestern Medical Center, 5323 Harry Hines Blvd, Bldg. E6.222D, Dallas, TX 75390–9155; Moffitt Cancer Center, H. Lee Moffitt Cancer Center and Research Institute, 2902 USF Magnolia Drive, Tampa, FL 33612; University of Southern California (USC), University of Southern California, Norris Comprehensive Cancer Center, 1450 Biggy Street; Norris Research Tower (NRT) 3505, Norris Comprehensive Cancer Center, Los Angeles CA 90033; University of Arizona (UAZ), Arizona Cancer Center at UMC-North, The University of Arizona Medical Center Surgical Oncology, PO Box 245131, Tucson, AZ 85724–5131; Arizona Cancer Center at UMC, North 3838 N. Campbell Ave, Tucson, AZ 85719; University of Washington (UWash), University of Washington, 825 Eastlake Ave, East Seattle, WA 98109–1023; Inova Health System (Inova), Inova Fairfax Hospital Cancer Center, FACS 3300 Gallows Rd, Fairfax, VA 22042; Mayo Clinic Scottsdale (Mayo AZ), Mayo Clinic–Scottsdale, 13400 E. Shea Blvd, Scottsdale, AZ 85259; University of Kansas (KUMC), University of Kansas Medical Center, 2330 Shawnee Mission Pkwy, Ste 210, Westwood, KS 66205; and Emory University (Emory), Emory University Winship Cancer Institute, 1365-C Clifton Road, NE, Atlanta, GA 30322.

: All patients provided signed informed consent to allow for research on their biospecimen samples in association with clinical outcome data.

: No individual patient data or individual patient images are included in this manuscript.

: Electronic figures were generated from R version 3.6.3, assembled and formatted using Adobe Illustrator, and embedded in the text body of the manuscript in Word as requested.