# I-SPY 2.2

Source: https://onco.cc/trials/i-spy-2-2/  
OnCo record `i-spy-2-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-17
- Also known as: I-SPY2.2; ISPY 2.2
- Registry id: NCT01042379
- Phase: platform
- Setting: High-risk early breast cancer: a sequential multiple assignment randomised design that starts with a new agent chosen by response-predictive subtype and escalates or de-escalates treatment according to MRI and biopsy response
- Sponsor: Quantum Leap Healthcare Collaborative
- Result: Ongoing; the first block results and de-escalation rates were reported from 2024.

## Sources

- ClinicalTrials.gov NCT01042379: https://clinicaltrials.gov/study/NCT01042379
- I-SPY Trials: I-SPY 2.2: https://www.ispytrials.org/i-spy-platform/i-spy2-2

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [MRI](https://onco.cc/technologies/mri/)
- drugs: [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Quantum Leap Healthcare Collaborative](https://onco.cc/companies/quantum-leap-healthcare-collaborative/)
- institutions: [UCSF Helen Diller Family Comprehensive Cancer Center](https://onco.cc/institutions/ucsf/)
- terms: [Master protocol (platform, basket and umbrella trials)](https://onco.cc/terms/master-protocol/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/), [Seamless, adaptive and Bayesian trial designs](https://onco.cc/terms/seamless-adaptive/)
- people: [Laura J. Esserman](https://onco.cc/people/laura-esserman/)

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