I-SPY Trials

An unprecedented and streamlined approach to clinical trial design

Advancing Clinical Trials

The I-SPY trials have been re-engineering the approach to clinical trials. Our goal is to get the right drug to the right patient at the time they will benefit most, and to achieve this faster than previous trial models. Additionally, we aim to significantly reduce the overall cost, time, and number of patients required to bring new drugs to market. The I-SPY trial program integrates and links Phase I (I-SPY Phase 1), Phase II (I-SPY 2), and future phases to build a pipeline of novel agents and accelerate the process of identifying the subset of high risk breast cancer patients that will benefit from these new agents, and get these drug to market.

I-SPY Phase 1 (Completed)

The I-SPY Phase 1 program was developed to help pharmaceutical companies and investigators meet the safety qualifications necessary for participation in I-SPY 2 and/or I-SPY 3 trials.

Similar to all phase I clinical trials, I-SPY Phase 1 is designed to determine drug safety. Additionally, it is designed to decrease the amount of time required to collect this data. This is done using innovative processes designed to reduce timelines including:

  • Master contract
  • Template protocols
  • I-SPY Phase 1 network sites, which allow accelerated expansion cohort enrollment, and provides earlier feedback for the preparation and inclusion of the agent in I-SPY 2 and I-SPY 3 protocols

The I-SPY Phase 1 network is comprised of seven trial locations. With each new phase 1 study, one site will serve as the lead with additional sites joining the expansion phase, as needed.


The focus of I-SPY 2 trial is on treating patients with stage 2-3 breast cancer at the time of primary diagnosis and therefore at the highest risk of progression. Patients are being accrued at 16 clinical study sites around the U.S. and Canada.

I-SPY 2 represents an unprecedented re-engineering of the clinical trial design process for Phase II clinical trials. Similar to all Phase II clinical trials, I-SPY 2 is designed to determine safety and efficacy of new treatments. However, by incorporating a number of highly innovative and unique features, the I-SPY 2 trial is also designed to decrease the time, the cost, and the number of patients required to efficiently bring new drug therapies to breast cancer patients who need them urgently.

Visit ispytrials.org to learn more

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