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Trial May Advance Personalized Medicine

An innovative study for women newly diagnosed with invasive breast cancer may open doors for speedy development of new medicines

Trial Starts: 7/7/2010

Written By Mary Alice Hartsock
Reviewed By Richard A. Michaelson, MD

If you are newly diagnosed with invasive breast cancer, you may be eligible to participate in a study measuring the effectiveness of novel medicines added to standard chemotherapy before surgery.

This study, sponsored by the Foundation for the National Institutes of Health, is called I-SPY 2 TRIAL, or the Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And Molecular Analysis. It will examine whether adding investigational medicines to standard chemotherapy medicines before surgery based on tumor characteristics will improve treatment. Investigational medicines are new medicines that have not yet been approved by the U.S. Food and Drug Administration (FDA) for breast cancer but may have been approved for other conditions or shown promise in earlier clinical studies.

This study uses neoadjuvant treatment, or chemotherapy given before surgery. Previous studies have shown neoadjuvant chemotherapy to be just as effective as post-surgical (adjuvant) chemotherapy. Neoadjuvant treatment has the added benefit of helping your doctors see how much the tumor shrinks from each treatment. It allows them to take several biopsies to see whether treatments impact the biology of the cancer cells, which may someday help researchers predict which cancers will respond to particular medicines.

Why Your Participation Matters

This study has two important goals: to find new targeted therapies that improve the effectiveness of chemotherapy, and to help doctors better understand which tumors respond to which treatments. Your participation could help answer these questions and may help other women receive more effective, personalized treatment.

The trial uses adaptive randomization, meaning future participants have a greater chance of being randomly assigned to a treatment that worked for participants with similar tumors. The design may significantly reduce the cost of and time to develop new, personalized medicines. If this study is successful, doctors may be able to know before surgery which medicines are more likely to work for specific types of tumors.


You are eligible to be screened for I-SPY if you have an invasive tumor at least 2.5 cm that has or has not traveled to your lymph nodes but not elsewhere in the body. You will need the following screening tests to find out if you can participate:

  • Breast MRI
  • Blood test
  • Core biopsy, in which a doctor uses a needle to remove a tumor tissue sample

These tests will identify the biomarkers, or cell characteristics, of the tumor with the goal of identifying the treatment that will work best for each unique tumor type. Your eligibility also depends on your risk for recurrence calculated using an investigational version of MammaPrint, a test that looks at the tumor’s genetic characteristics.

Trial Design

You will be randomly assigned by a computer to a group receiving standard neoadjuvant chemotherapy (paclitaxel (Taxol)) alone (the control group) or standard neoadjuvant chemotherapy plus an investigational medicine (the study group). If the cancer is HER2 positive and you take standard chemotherapy alone, you will receive trastuzumab (Herceptin). After 12 weeks of treatment, participants in both groups will receive four rounds of an anthracycline and cyclophosphamide (Cytoxan), also known as AC chemotherapy. You will then have surgery. You will always know what treatment you are receiving.

To test how your treatment is working, you will receive three MRI (Magnetic Resonance Imaging) scans and blood draws. After surgery, you and your doctor will decide whether you need further treatment. The study coordinators will monitor you for five years.

Safety and Side Effects

You have an 80 percent chance of receiving an investigational medicine in this trial. These medicines have been tested in humans, so researchers know how much you can take safely. Talk with your doctor before treatment to learn ways to manage side effects.

Learn More

For more information, visit Contact about joining the trial or if you are a provider and want to open I-SPY 2 at your site.