I-Spy Clinical Trial Description
(info taken from http://www.ispytrials.org/patient-site)


The I-SPY 2 TRIAL is a clinical trial (Screening, Treatment, Surgery) 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


About the Trial

The I-SPY 2 TRIAL is enrolling women with newly diagnosed invasive breast cancer. If your tumor is 2.5 cm or larger in size, you are eligible to be SCREENED for this study. The purpose of the screening phase is to find out more about your cancer and whether you are eligible to participate in the treatment phase of the study.


Screening Phase

A study doctor and study coordinator will discuss the trial with you and give you a screening consent form that explains the screening study procedures and tests. 

The screening phase includes taking some tissue from your tumor to do some tests to find out more about your cancer. The tissue can be collected either at the time of your diagnostic core biopsy or, if you have already had a diagnostic core biopsy, you will have another core biopsy prior to your treatment for the purposes of this study. You will also have an MRI scan of your breasts and a blood draw to find out more about your cancer. 


To determine if you are eligible for the treatment phase of this study, the study will use common biomarkers used in breast cancer. These include: Estrogen Receptor (ER) status, Progesterone Receptor (PR) status, Her2 receptor status. The study will also use TargetPrint Her2 and MammaPrint risk score, which are approved research tests. TargetPrint Her2 is another test of the Her2 receptor that looks at the amount of these genes in your tumor. MammaPrint is a test to find out if your cancer is at high risk for recurrence if you did not have any treatment, other than surgery, for your cancer. All of these biomarkers will be used to help determine whether you are eligible to join the trial. 

To be eligible for this trial, your cancer needs to be one of the following categories:

-  Mammaprint High risk

-  Mammaprint Low risk, ER Negative

-  Mammaprint Low risk, ER Positive, Her2 Positive


If your cancer does not match one of the groups listed or if you have evidence of cancer in another part of your body, other than your lymph nodes, you will not be eligible to join the I-SPY 2 TRIAL.


Treatment Phase

If you are found to be eligible for the treatment phase of this study, you will be assigned to receive either standard chemotherapy or standard chemotherapy with an investigational drug before having surgery. Standard chemotherapy in this trial is Paclitaxel, with Trastuzumab if you are Her2 positive, followed by Anthracycline and Cyclophosphamide, also known as AC.

You will be given a treatment consent form by your study doctor or study coordinator that will give you information about the drugs you have been assigned to receive. If you decide to join the treatment phase of this trial, your tumor will be monitored by having multiple MRI scans throughout your treatment. You will also have additional blood draws and 1 additional core biopsy for research purposes. Below is a diagram of all of the study procedures you will have while you are in this trial.


Surgery Phase

A tissue sample will be taken during surgery. After you have surgery, you and your doctors will determine what, if any, additional treatment would be in your best interest. You may be eligible for other clinical trials.