Common Questions by Patients

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

The screening phase of this study will last about 2 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 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 her tumor characteristics. The study will learn how effective the treatments are for the group of women who received 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 from 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 that 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 Estrogen Receptor (ER) status, Progesterone Receptor (PR) status, 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 yet know 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 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 she completes 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.

If I join I-SPY 2, how many MRI scans will I have, and will I know the results?

You will have 1 MRI scan as part of the screening phase, and another 3 as part of the treatment phase:

First MRI scan: During the screening phase of this study, before you start treatment.
Second MRI scan: At the end of your 3rd week of treatment.
Third MRI scan: In between your 2 different types of treatment.
Fourth MRI scan: Before you have surgery.
All MRI scan results will be available to you and your doctors. For more information about MRI scans, visit MRI scans.

If I join I-SPY 2, how many times will tissue be collected, and how will the tissue be collected?

You will have a total of 2 research core biopsies. Tissue will also be taken at the time of your surgery:

First core biopsy: Done during the screening phase of this study, before you start treatment, to make sure you are eligible to join the treatment phase of this study.
Second core biopsy: At the end of your 3rd week of treatment.
Tissue sample: At the time of your surgery.
For each study core biopsy, a needle about the size of pencil lead (diameter of 1.6 mm) will be inserted into your breast 4 times. A small amount of tissue will be removed each time. This procedure will be done with local anesthetic to minimize any discomfort and pain you may have from the biopsy.

A tissue sample will also be collected at the time of your surgery. This means that you may have your tissue collected for a total of 3 times if you participate in both the screening and treatment phases of this study.

If I join I-SPY 2, how many times will blood be collected for research purposes, and how will the blood be collected?

You will have blood collected for research 1 time during the screening phase, and 3 more times during the treatment phase of this study. This is in addition to the blood draws required as part of your standard treatment. To help reduce the number of times you will be pricked with a needle, the study will collect your blood at the time your catheter is placed for your study MRI scans or during a routine blood test.

What will my tissue and blood samples be used for in this study?

A portion of the tissue collected during the screening phase will be used to run the MammaPrint risk score and TargetPrint Her2 test. A number of other research tests will also be done on your tissue and blood samples collected as part this study. These tests will help the researchers learn more about your cancer, including molecular (cell) changes that occur in your tumor as a result of your treatment. The goal of these other research tests is to identify biomarker(s) that can be used to predict a woman’s response to a specific therapy.

Will I be told the results of the research tests done from my tissue and blood samples?

After your initial diagnostic core biopsy and at the completion of your surgery, your doctors will receive a report that has information about the standard biomarkers: Estrogen Receptor (ER), Progesterone Receptor (PR), and Her2 receptor. Your MammaPrint risk score and TargetPrint result will also be shared with you and your doctors as part of the screening phase of I-SPY 2. These biomarkers will be used to decide what treatment you will be assigned.

Information about other research tests done on your tissue and blood samples will not be provided to you and will not affect the care that you receive. The study does not know what the results of the research tests might mean to you and this is why they are being studied. The study will learn what the results of these research tests mean and how this information could be useful for future cancer 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 is based, in part, on the results from I-SPY 1.