Before You Enroll

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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 (Investigation of Serial Studies to Predict Your Therapeutic Response 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 consist of 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.

Things to Consider Before Joining the I-SPY 2 TRIAL

Before joining the I-SPY 2 TRIAL there are several things to consider.

You should understand what clinical trials are and the purpose of each. To find out more visit www.cancer.gov/clinicaltrials/learning

You should understand all of the study procedures that you would need to complete as part of this trial. These include:

Breast MRI scans
Breast Core Biopsies
Research Blood Draws
Receiving Chemotherapy Treatment Before Surgery (Neoadjuvant Treatment)
Possibly Receiving an Investigational Drug as Part of Your Treatment
You should understand the costs related to procedures while participating in this trial.

Frequently Asked Questions About Trial Costs:

Who will pay for my MRI scans?

First MRI scan: Your insurance will cover the cost of the MRI unless it is done for study purposes only.
Second MRI scan: The study will cover the cost of this MRI.
Third MRI scan: The study will cover the cost of this MRI.
Fourth MRI scan: Your insurance will cover the cost of the MRI unless it is done for study purposes only.
The study will pay for up to 3 of the 4 MRI scans. One or more of the MRI scans will be done as part of your standard treatment and will be billed to your insurance company. MRI scans that are billed to your insurance company may result in an out-of-pocket cost to you.

Who will pay for my core biopsies?

First core biopsy: The study will cover the cost of the core biopsy if it was done only for the purpose of this study.
Second core biopsy: The study will cover the cost of the core biopsy.

Who will pay for my research blood draws?

The study will cover the cost of the blood collected for research in this study.

Who will pay for the investigational drug that I may be assigned?

The study will cover the cost of the investigational drug if you have been assigned to receive one. Any other medications will be the responsibility of you and/or your health plan/insurance company.

Who will pay for travel for the extra trips I may have to the hospital?

There will be ways the study can help reduce the cost related to travel or parking for study visits. Please ask your study doctor or coordinator for more details.