The I-SPY clinical trial platform was designed to accelerate clinical development of neoadjuvant treatments for early-stage breast cancer. Although it is not without limitations, it provides a model for future response-adapted clinical trials.
This is a preview of subscription content, access via your institution
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$32.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$259.00 per year
only $21.58 per issue
Buy this article
- Purchase on SpringerLink
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Khoury, K. et al. Nat. Med. https://doi.org/10.1038/s41591-024-03266-2 (2024).
Shatsky, R. A. et al. Nat. Med. https://doi.org/10.1038/s41591-024-03267-1 (2024).
Esserman, L. J. et al. J. Clin. Oncol. 30, 3242–3249 (2012).
Barker, A. et al. Clin. Pharmacol. Ther. 86, 97–100 (2009).
Kidwell, K. M. Clin. Trials 11, 445–456 (2014).
Schmidli, H. et al. Clin. Pharmacol. Ther. 107, 806–816 (2020).
Prat, A. et al. Clin. Cancer Res. 20, 511–521 (2014).
Schmid, P. et al. N. Engl. J. Med. 382, 810–821 (2020).
McArthur, H. et al. Cancer Res. 84, PO1-20-13 (2024). (Supp. 9).
Pérez-García, J. M. et al. Lancet 403, 1649–1659 (2024).
Gebhart, G. et al. J. Nucl. Med. 65, 708–713 (2024).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
J.P.-G. reports consulting/advisory role for Lilly, Roche, Eisai, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Gilead and MSD; travel compensation from Roche; and employment at MEDSIR. G.A. reports honoraria from MEDSIR. M.G. has received support for attending meetings and/or travel from AstraZeneca, Gilead Sciences, Roche and Pfizer and has received honoraria from AstraZeneca, Gilead Sciences and Pfizer. A.L.-C. reports receiving research support from Roche, Agendia, Lilly, Pfizer, Novartis, Merck Sharp & Dohme, Gilead and Daiichi Sankyo; serving as a consultant/advisor for Lilly, Roche, Pfizer and Novartis; participation in speakers’ bureaus for Lilly, AstraZeneca and Merck Sharp & Dohme; travel support from Roche, Pfizer and AstraZeneca; and stock or other ownership of MEDSIR and Initia-Research. J.C. reports serving as a consultant/advisor for Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics and Expres2ion Biotechnologies; receiving honoraria from Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp & Dohme and Daiichi Sankyo; research funding to the institution from Roche, Ariad Pharmaceuticals, AstraZeneca, Baxalta/Servier Affaires, Bayer Healthcare, Eisai, F. Hoffman–La Roche, Guardant Health, Merck Sharp & Dohme, Pfizer, PIQUR Therapeutics, Puma C and Queen Mary University of London; holding stock in MEDSIR, Nektar Pharmaceuticals and Leuko (relative); receiving travel and accommodation expenses from Roche, Novartis, Eisai, Pfizer, Daiichi Sankyo, AstraZeneca and Gilead; and holding patents, including one for pharmaceutical combinations of a PI3K inhibitor and a microtubule destabilizing agent (US 2019/0338368 A1).
Rights and permissions
About this article
Cite this article
Pérez-García, J., Antonarelli, G., Gion, M. et al. Moving toward response-adapted trials in oncology. Nat Med 30, 3426–3428 (2024). https://doi.org/10.1038/s41591-024-03346-3
Published:
Issue date:
DOI: https://doi.org/10.1038/s41591-024-03346-3
