Participation in I-SPY 2

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.

My Participation in I-SPY 2

Screening Phase
Treatment Phase
Commonly Asked Questions
Things to Consider Before Joining



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 (also shown in the diagram below).

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.  All of these procedures and tests will be done to find out if you are eligible to join the treatment phase of this study.

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 if you are eligible to join the trial.  For more information about what a biomarker is, please visit What is a biomarker?

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

  1. MammaPrint High Risk score
  2. MammaPrint Low Risk score and ER negative
  3. MammaPrint Low Risk score and ER positive and Her2 positive

If your cancer does not match one of the groups listed or 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. Please discuss other treatment options with your doctor.



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.  For more information about having treatment before surgery, visit What is neoadjuvant therapy?

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 would have while you are in this trial.

I-SPY 2 TRIAL Study Procedures

I-SPY 2 TRIAL Study Procedure


Post-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. To find out more information about other clinical trials for which you may be eligible, visit breastcancertrials.org.


I-SPY 2 Patient Study Schedule

I-SPY 2 Patient Schedule



Commonly Asked Questions about Participating in the I-SPY 2 TRIAL

If I join I-SPY 2, how long will I be in the study?

The screening phase of this study will last about 2-4 weeks.   If you are found to be eligible and join the treatment phase of this study, it will last until you have surgery, about 6 months.

After your surgery, you and your doctors will choose what further treatment, if any, you will receive.  A study coordinator will continue to monitor your health for 5 years by getting records from your regular visits with your doctors.

If I join I-SPY 2, how soon will I be able to start my treatment?

The screening phase of this study will last about 2-4 weeks.  This time is used to find out what your tumor characteristics are and to assign you a study treatment.  This time is also used for you and your doctor to do other standard tests and procedures needed before you start treatment.  Deciding to join the screening phase of I-SPY 2 should not delay your treatment.

If I join I-SPY 2, how likely am I to receive an investigational drug?

Patients in I-SPY 2 will be assigned to standard chemotherapy or standard chemotherapy with an investigational drug.  You will have an 80% chance of receiving investigational drug and a 20% chance of receiving just standard chemotherapy. 

A patient’s assigned treatment will depend on their tumor characteristics.  The study will learn how effective the treatments are for the group of women who receive them based on the information gathered from the multiple MRI scans and the amount of cancer that remains at the time of their surgery.  Future patients entering the study have a higher chance of being assigned to the treatments that appear to be working for the group of women with similar tumor characteristics who have already received these treatments.  This will hopefully allow us to provide better treatment for patients in this trial and for patients in the future.  The investigational treatments may be better than, worse than, or no different than standard chemotherapy.  The goal of the I-SPY 2 TRIAL is to find out which investigational treatment(s), if any, are better than standard chemotherapy.

How does the I-SPY 2 TRIAL assign which treatment I receive?

After you have completed the required tests and procedures during the screening phase and it is determined you are eligible for the treatment phase, a computer will randomize you to a treatment group, taking into account your tumor characteristics.  By doing this, you have a higher chance of receiving treatment that targets your particular type of tumor.  The tumor characteristics we will use are ER, PR, and Her2 status, along with MammaPrint risk score.  Being randomized means that you will be put into a treatment group by chance.

Can I choose which treatment I want to receive?

No.  A computer will randomize you into a treatment group.  Once you are put into a treatment group, you must receive the treatment assigned to you in order to continue participating in the trial.  We do not know yet which investigational drugs best treat which tumor types.  The purpose of this trial is to learn this and make the drugs that are effective available to those who will benefit from them.

Can I switch investigational drugs during the treatment phase of I-SPY 2?

After you have been randomized to a treatment group, you will not be allowed to switch treatment groups as part of this study.  If you or your doctor feel that it is not in your best interest to continue in the treatment phase of this trial, you can stop participating in the trial at any time.  Your participation in any clinical trial is voluntary.

Does my participation in I-SPY 2 affect other patients in I-SPY 2?

The I-SPY 2 TRIAL is designed to learn from every patient as they complete the treatment phase of the trial.  How each patient responds to the treatment she was assigned, will impact future women who join the trial.  A patient’s response to her treatment is determined by measuring the size of her tumor by MRI over the course of her treatment and by measuring the amount of tumor left at the time of her surgery.

You could have a positive response to a treatment, meaning your tumor gets smaller.  You could have a negative response to a treatment, meaning your tumor does not get smaller or becomes larger.  If you have a positive response to your treatment, future women that join this study with similar tumor characteristics to you will have a greater chance of being randomized to the same treatment group as you.  On the other hand, if you have a negative response to a treatment, future women that join the study who have a similar tumor as yours will have a smaller chance of being randomized to the same treatment as you.  This type of randomization is called adaptive randomization.  This is how the study is able to learn from each patient while she is in the study.  This will allow the study to test several investigational drugs in a short period of time and may help tailor breast cancer treatment for patients.

This trial is called I-SPY 2.  What was I-SPY 1 and what was learned from that trial?

The I-SPY 1 TRIAL started in 2003.  The goal of I-SPY 1 was to see if we could predict how a woman would respond to standard chemotherapy by using multiple MRI scans and biomarkers.  No investigational drugs were tested in I-SPY 1.  The goal of I-SPY 2 is to take what was learned in I-SPY 1 and more quickly test which investigational drugs benefit patients and what tumor characteristics can be used to identify which future patients should receive those investigational drugs.  The selection of biomarkers and MRI markers for I-SPY 2 are based, in part, on the results from I-SPY 1.


More Information About Breast Cancer

For information about breast cancer, visit www.cancer.gov/cancertopics/types/breast

For information about clinical trials, visit www.cancer.gov/clinicaltrials/learningabout

For information about breast cancer clinical trials that are open and enrolling patients, visit www.breastcancertrials.org

For information about support services for those affected by cancer, visit www.cancercare.org