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I-SPY 2.2 takes the next step: instead of adding a new drug to the same chemotherapy for everyone, it assigns treatment by a tumour's predicted response type, checks with scans and biopsies whether the tumour is disappearing, and lets women who respond early skip further chemotherapy.
I-SPY 2.2 began in 2022 under the same registration as I-SPY 2. It replaces the fixed backbone with three blocks. Block A gives an experimental treatment matched to the tumour's response-predictive subtype (defined by hormone receptor, HER2, an immune signature and a DNA repair deficiency signature). Women whose MRI and biopsy show the tumour has gone go straight to surgery; the rest move to block B, standard chemotherapy or a subtype-specific standard, and if still not responding to block C, the best current treatment for that subtype. The design is a sequential multiple assignment randomised trial, so each woman's path is set by her own early response.
The aim is to raise the pathological complete response rate while lowering the amount of chemotherapy given, and to find, for each subtype, the treatment that works alone. Early results reported from 2024 have described complete response rates by block for the first experimental agents and the share of women who could avoid the chemotherapy blocks altogether.
Shares 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, Quantum Leap Healthcare Collaborative, Laura J. Esserman, Seamless, adaptive and Bayesian trial designs.
Shares Laura J. Esserman, Master protocol (platform, basket and umbrella trials), UCSF Helen Diller Family Comprehensive Cancer Center, Pathologic complete response (pCR).
Shares Laura J. Esserman, UCSF Helen Diller Family Comprehensive Cancer Center, Pathologic complete response (pCR), Breast cancer (all types).
Shares Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, HER2-positive breast cancer, Breast cancer (all types).
Shares Laura J. Esserman, UCSF Helen Diller Family Comprehensive Cancer Center, Triple-negative breast cancer (TNBC).
Shares Pathologic complete response (pCR), HER2-positive breast cancer, Breast cancer (all types), Triple-negative breast cancer (TNBC).
Shares Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, HER2-positive breast cancer, Triple-negative breast cancer (TNBC).
Shares Laura J. Esserman, UCSF Helen Diller Family Comprehensive Cancer Center, Breast cancer (all types).