# I-SPY 1 (CALGB 150007/150012, ACRIN 6657)

Source: https://onco.cc/trials/i-spy-1/  
OnCo record `i-spy-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

I-SPY 1 followed women having chemotherapy before breast surgery with repeated MRI scans and biopsies, and showed that a tumour vanishing completely (a pathological complete response) predicted long-term survival, especially in the aggressive subtypes.

## Summary

I-SPY 1 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) ran from 2002 to 2006 across nine United States centres, led by Laura Esserman at UCSF with the Cancer and Leukemia Group B and the American College of Radiology Imaging Network. Women with tumours of three centimetres or more received standard anthracycline and taxane chemotherapy before surgery while the study collected MRI scans, core biopsies and blood at set points.

Its findings set the rules for everything that followed: a pathological complete response, no invasive cancer left in the breast and nodes at surgery, predicted recurrence-free survival, and the prediction was strongest in triple-negative and HER2-positive disease and in tumours the MammaPrint test called high risk. Change in tumour volume on MRI after the first cycles also predicted response, which made early imaging a way to tell quickly whether a drug was working.

The trial built the biomarker-defined subtypes, the imaging protocol and the multi-centre infrastructure that I-SPY 2 turned into a permanent platform.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-17
- Also known as: I-SPY 1 TRIAL; ISPY1
- Phase: observational
- Setting: Stage 2 and 3 breast cancer treated with chemotherapy before surgery: serial MRI and biopsies to learn which early signals predict outcome
- Sponsor: CALGB and ACRIN (NCI), led from UCSF
- Result: Pathological complete response and early MRI volume change predicted recurrence-free survival, most strongly in triple-negative, HER2-positive and MammaPrint high-risk tumours.

## Sources

- I-SPY Trials: I-SPY 1: https://www.ispytrials.org/i-spy-platform/i-spy1
- Esserman et al., Journal of Clinical Oncology 2012: pathologic complete response predicts recurrence-free survival more effectively by cancer subset (I-SPY 1): https://ascopubs.org/doi/10.1200/JCO.2011.39.2779

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Gene-expression prognostic assays](https://onco.cc/technologies/gene-expression-prognostic-assays/), [MRI](https://onco.cc/technologies/mri/)
- drugs: [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- 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/)
- people: [Laura J. Esserman](https://onco.cc/people/laura-esserman/)

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