I-SPY Clinical TrialS

Advancing Clinical Trial Sponsorship


I-SPY is a re-engineered 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 do this faster. 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 Phases I (I-SPY Phase 1), Phase II (I-SPY 2), and, eventually, Phase III (I-SPY 3) 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 the drug to market.


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.


The I-SPY 3 TRIAL is an international confirmatory trial of successful agents who have graduated from the I-SPY 2 TRIAL. Similar to all Phase III clinical trials, I-SPY 3 is designed to confirm the efficacy of new treatments. However, the goal of the I-SPY 3 TRIAL is to accelerate the phase III testing of agents through a variety of mechanisms including:

• Targeted eligibility criteria for subtypes of breast cancer most likely to respond

• Serial interim analyses to allow for informed and efficient decision making

• Adaptive design to optimize sample size determination and maximize potential for success

• Reducing the number of patients required

Similar to the I-SPY 2 TRIAL design, I-SPY 3 is a standing trial consisting of a master protocol and IND with shared control arms aimed to reduce time and costs. The trial also utilizes parallel approval pathways for US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and is currently developing a novel IT infrastructure to support its expediency.

The I-SPY 3 TRIAL consortium works with sites across the European Union, Australia, New Zealand, Canada, and Japan, with a focus on partnering with high accruing sites to reduce time and costs. Academic Research Organizations (ARO) also play an important role in the trial by contributing clinical trial expertise, local and regional knowledge, and global reach. The trial leverages and combines best practices from these groups as well as the trial’s Clinical Research Organization (CRO).