I‐SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

By A. Barker, CC Sigman, G. Kelloff, N. Hylton, D. Berry, L. Esserman. Clinical pharmacology and therapy, 2009

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Pathological complete response after neoadjuvant chemotherapy and impact on breast cancer recurrence and survival: a comprehensive meta-analysis (2020, neutral): “I-SPY (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) 2, a multicenter, randomized, phase II trial with multiple arms and pCR as the primary endpoint, utilizes an adaptive strategy for matching targeted therapies for breast cancer with the p”
Multi-armed Bandit Models for the Optimal Design of Clinical Trials: Benefits and Challenges (2015, methodology): “For example, this facet has been built into the I-SPY 2 trial investigating tumour-speciﬁc treatments for breast cancer from the start (Barker et al., 2009).”
Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer: An Analysis of the Ongoing Phase 2 Adaptively Randomized I-SPY2 Trial. (2020, neutral): “HR positive/ERBB2 negative 30 (17-43) 13 (7-19) >99.”
Economics, Fairness and Algorithmic Bias (2020, neutral): “Alternatively, researchers could use adaptive trial design (Barker et al., 2009; Palmer and Rosenberger, 1999) such as multi-armed bandits (Joseph et al., 2016; Jabbari et al., 2017; Dimakopoulou et al., 2017) to balance exploration and exploitation.”