I-SPY 2 TRIAL is a Groundbreaking clinical trial that combines Novel Trial Design and BioMarker Analysis to identify potentially Life Saving new personalized cancer treatments


The Biomarkers Consortium, a unique public-private partnership that includes the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH), has launched a highly anticipated clinical trial to help screen promising new drugs being developed for women with high risk, fast-growing breast cancers—women for whom an improvement over standard treatment could dramatically change the odds of survival.

The I-SPY 2 TRIAL employs a groundbreaking clinical trial model that uses genetic or biological markers (“biomarkers”) from individual patients’ tumors to screen promising new treatments, identifying which treatments are most effective in specific types of patients. In addition, an innovative adaptive trial design will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.

This large-scale trial involves a unique collaboration by scientists from the National Cancer Institute (NCI), FDA and nearly 20 major cancer research centers across the country. Study results will be made broadly available to the entire cancer research and development community.

I-SPY 2 has the potential to significantly reduce the cost of drug development and speed the process of screening drugs with the goal of bringing safe and effective new drugs to market more efficiently. Currently, it takes more than $1 billion, twelve to fifteen years, and thousands of patient volunteers to get a single drug to market. I-SPY 2 was developed to allow the activity of drugs to be assessed much earlier in the research process, potentially enabling drugs to be developed and approved using fewer patients, less time and far fewer resources. The goal is to shave several years and hundreds of millions of dollars off the current process.

The I-SPY 2 TRIAL will focus on treatment in the neoadjuvant therapy setting, in which chemotherapy is given to patients to reduce tumor size before surgery. All patients will receive the current standard of care and most participants will receive one investigational drug. A distinctive feature of the trial is that it will screen multiple drugs from multiple companies—up to 12 different cancer drugs over the course of the trial. In order to do this, FNIH received a master Investigational New Drug (IND) approval from the FDA—which allows the I-SPY 2 TRIAL team to graduate, drop and add drugs seamlessly throughout the course of the trial without having to stop the trial to write a whole new protocol. This will dramatically reduce the time it takes to move from one drug to another in the trial.

I-SPY 2 Launch


Over the past twenty years, significant progress has been made in the detection and treatment of breast cancer. In fact, many women who now present with early stage disease have excellent outcomes due to improved therapy. One of the most significant findings over the past decade has been the realization that breast cancer is not a singular disease. This helps explain why some women benefit greatly from current therapies whereas other women benefit less and some seem to be resistant to treatment altogether. It also suggests that in order to achieve the best results for patients we need the ability to provide personalized treatments that are tailored to an individual patient based on that patient’s particular tumor profile.

The development and use of trastuzumab, a drug that effectively targets a particular type of breast cancer tumor (HER2+), is an excellent example of advances in tailoring breast cancer treatment to biology. Trastuzumab has been an extremely important addition to the breast cancer treatment arsenal. However, we need many more targeted treatments in our toolkit if we are to effectively treat the many forms of breast cancer. And we cannot afford the ten to twenty years it takes for a traditional trial to yield a successful drug, as it took for trastuzumab. If we are going to be able to develop more personalized treatments in an accelerated timeframe, we need to develop a new type of clinical trial.

Specifically, we need to be able to:

  • Introduce and rapidly evaluate new drugs
  • Target women at high risk for recurrence
  • Intervene at the time of primary cancer diagnosis, rather than waiting until patients develop metastatic disease

And that is precisely what we have done with the I-SPY 2 TRIAL.

I-SPY 2 TRIAL Introductory Video:


New! – Watch an NBC Nightly News video segment about I-SPY 2 – New moves to fast track breast cancer drug trials

Watch a PBS video – Myths Surrounding Clinical Trials.

Download a brochure published by the 2011 Alexandria Summit on Oncology – ISPY2 brochure

Download a patient brochure – FNIH Patient Brochure

We need your support.

The dramatic breakthroughs from I-SPY 2 depend on public support. Please help us accelerate the pace of new cancer treatments and dramatically reduce their costs to patients.

Breast cancer clinical trials matching website:

BreastCancerTrials.org was developed specifically for women and men interested in breast cancer trials. On this website you can:

  • Learn about the benefits of taking part in a clinical trial, and the questions to ask before you do.
  • Use the trial matching service to find trials that might be right for you. Contact research sites through our unique messaging service.
  • Browse trials with BCT QuickViews.