Haiyun Wang1, Douglas Yee1. 1. Masonic Cancer Center, University of Minnesota, MMC 806, 420 Delaware St SE, Minneapolis, MN 55455, USA.
Abstract
PURPOSE OF REVIEW: The I-SPY 2 trial is an adaptive clinical trial platform designed to improve outcomes in high-risk breast cancer patients by testing new drugs in the neoadjuvant setting. The intent of this review is to discuss background, study structure, innovation, and outcomes of the I-SPY 2 trial. RECENT FINDINGS: I-SPY 2 evaluates new agents combined with standard therapy with pathologic complete response (pCR) as the primary endpoint. I-SPY-2 uses clinical biomarkers to classify breast cancer into 10 subtypes, with Bayesian adaptive randomization to allow individualized patient assignment to therapy arms to maximize treatment effects. A total of 7 drugs have graduated from I-SPY 2. Multiple new agents are currently in active enrollment in I-SPY 2. SUMMARY: I-SPY 2 uses an individualized approach in clinical trial design to improve high-risk breast cancer outcomes. The purpose of this review is to encourage further research and innovation in this area and bring more precise treatment options to breast cancer patients.
PURPOSE OF REVIEW: The I-SPY 2 trial is an adaptive clinical trial platform designed to improve outcomes in high-risk breast cancer patients by testing new drugs in the neoadjuvant setting. The intent of this review is to discuss background, study structure, innovation, and outcomes of the I-SPY 2 trial. RECENT FINDINGS: I-SPY 2 evaluates new agents combined with standard therapy with pathologic complete response (pCR) as the primary endpoint. I-SPY-2 uses clinical biomarkers to classify breast cancer into 10 subtypes, with Bayesian adaptive randomization to allow individualized patient assignment to therapy arms to maximize treatment effects. A total of 7 drugs have graduated from I-SPY 2. Multiple new agents are currently in active enrollment in I-SPY 2. SUMMARY: I-SPY 2 uses an individualized approach in clinical trial design to improve high-risk breast cancer outcomes. The purpose of this review is to encourage further research and innovation in this area and bring more precise treatment options to breast cancer patients.
Authors: Brian M Alexander; Patrick Y Wen; Lorenzo Trippa; David A Reardon; Wai-Kwan Alfred Yung; Giovanni Parmigiani; Donald A Berry Journal: Neuro Oncol Date: 2013-07-14 Impact factor: 12.300
Authors: Hope S Rugo; Olufunmilayo I Olopade; Angela DeMichele; Christina Yau; Laura J van 't Veer; Meredith B Buxton; Michael Hogarth; Nola M Hylton; Melissa Paoloni; Jane Perlmutter; W Fraser Symmans; Douglas Yee; A Jo Chien; Anne M Wallace; Henry G Kaplan; Judy C Boughey; Tufia C Haddad; Kathy S Albain; Minetta C Liu; Claudine Isaacs; Qamar J Khan; Julie E Lang; Rebecca K Viscusi; Lajos Pusztai; Stacy L Moulder; Stephen Y Chui; Kathleen A Kemmer; Anthony D Elias; Kirsten K Edmiston; David M Euhus; Barbara B Haley; Rita Nanda; Donald W Northfelt; Debasish Tripathy; William C Wood; Cheryl Ewing; Richard Schwab; Julia Lyandres; Sarah E Davis; Gillian L Hirst; Ashish Sanil; Donald A Berry; Laura J Esserman Journal: N Engl J Med Date: 2016-07-07 Impact factor: 91.245
Authors: John W Park; Minetta C Liu; Douglas Yee; Christina Yau; Laura J van 't Veer; W Fraser Symmans; Melissa Paoloni; Jane Perlmutter; Nola M Hylton; Michael Hogarth; Angela DeMichele; Meredith B Buxton; A Jo Chien; Anne M Wallace; Judy C Boughey; Tufia C Haddad; Stephen Y Chui; Kathleen A Kemmer; Henry G Kaplan; Claudine Isaacs; Rita Nanda; Debasish Tripathy; Kathy S Albain; Kirsten K Edmiston; Anthony D Elias; Donald W Northfelt; Lajos Pusztai; Stacy L Moulder; Julie E Lang; Rebecca K Viscusi; David M Euhus; Barbara B Haley; Qamar J Khan; William C Wood; Michelle Melisko; Richard Schwab; Teresa Helsten; Julia Lyandres; Sarah E Davis; Gillian L Hirst; Ashish Sanil; Laura J Esserman; Donald A Berry Journal: N Engl J Med Date: 2016-07-07 Impact factor: 91.245
Authors: Sandra M Swain; José Baselga; Sung-Bae Kim; Jungsil Ro; Vladimir Semiglazov; Mario Campone; Eva Ciruelos; Jean-Marc Ferrero; Andreas Schneeweiss; Sarah Heeson; Emma Clark; Graham Ross; Mark C Benyunes; Javier Cortés Journal: N Engl J Med Date: 2015-02-19 Impact factor: 91.245
Authors: Joseph A Sparano; Robert J Gray; Della F Makower; Kathleen I Pritchard; Kathy S Albain; Daniel F Hayes; Charles E Geyer; Elizabeth C Dees; Matthew P Goetz; John A Olson; Tracy Lively; Sunil S Badve; Thomas J Saphner; Lynne I Wagner; Timothy J Whelan; Matthew J Ellis; Soonmyung Paik; William C Wood; Peter M Ravdin; Maccon M Keane; Henry L Gomez Moreno; Pavan S Reddy; Timothy F Goggins; Ingrid A Mayer; Adam M Brufsky; Deborah L Toppmeyer; Virginia G Kaklamani; Jeffrey L Berenberg; Jeffrey Abrams; George W Sledge Journal: N Engl J Med Date: 2018-06-03 Impact factor: 91.245
Authors: Tesa M Severson; Denise M Wolf; Christina Yau; Justine Peeters; Diederik Wehkam; Philip C Schouten; Suet-Feung Chin; Ian J Majewski; Magali Michaut; Astrid Bosma; Bernard Pereira; Tycho Bismeijer; Lodewyk Wessels; Carlos Caldas; René Bernards; Iris M Simon; Annuska M Glas; Sabine Linn; Laura van 't Veer Journal: Breast Cancer Res Date: 2017-08-25 Impact factor: 6.466
Authors: Daniel Clark Files; Michael A Matthay; Carolyn S Calfee; Neil R Aggarwal; Adam L Asare; Jeremy R Beitler; Paul A Berger; Ellen L Burnham; George Cimino; Melissa H Coleman; Alessio Crippa; Andrea Discacciati; Sheetal Gandotra; Kevin W Gibbs; Paul T Henderson; Caroline A G Ittner; Alejandra Jauregui; Kashif T Khan; Jonathan L Koff; Julie Lang; Mary LaRose; Joe Levitt; Ruixiao Lu; Jeffrey D McKeehan; Nuala J Meyer; Derek W Russell; Karl W Thomas; Martin Eklund; Laura J Esserman; Kathleen D Liu Journal: BMJ Open Date: 2022-06-06 Impact factor: 3.006