The Biomarkers Consortium Launches I-SPY 2 Breast Cancer Clinical Trial

Today most women with breast cancer receive standard chemotherapy. We know that some breast cancers respond well to standard chemotherapy but some do not. The I-SPY 2 TRIAL (Iinvestigation of Serial Studies to Predict Your Therapeutic Respouse with Imaging And moLecular Analysis 2) is a clinical trial for women with newly diagnosed locally advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone before having surgery.

The treatment phase of this trial will be testing multiple investigational drugs that are thought to target the biology of each participant’s tumor. The trial will use the information from each participant who completes the study treatment to help decide treatment for future women who join the trial. This will help the study researchers learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics. The I-SPY 2 TRIAL will test the idea of tailoring treatment by using molecular tests to help identify which patients should be treated with investigational drugs. Results of this trial may help make investigational drugs available to more women in the future.

More Information About Breast Cancer


Related Information:

I-SPY 2 featured in PBS “Need to Know” video series

Read a Wall Street Journal article about I-SPY 2

New! Watch a PBS video – Myths Surrounding Clinical Trials

Download a Patient Brochure

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.

Biomarkers Consortiuma program of the Foundation for the National Institutes for Health
I-SPY 2 is sponsored by the Biomarkers Consortium, a unique public-private partnership led by the Foundation for the National Institutes of Health that includes the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and a large number of partners from major pharmaceutical companies, leading academic medical centers, non-profit and patient advocacy groups.