Frequently Asked Questions

  • We hope that these common questions and answers help you decide whether the I-SPY 2 Trial is right for you.
  • The resources on the EXPERTS EXPLAIN page may also help you decide.
  • You can use the National Cancer Institute dictionary at the bottom of the page to find the meanings of terms that are not familiar to you.

Deciding whether to participate

What is a clinical trial and why should I consider participating in a cancer
clinical trial?

What is the I-SPY 2 Trial?

Who is eligible to participate?

How does the trial work? What are the screening criteria?

What else should I know as I consider whether to join the I-SPY 2 Trial?

Who may I speak with if I have more questions about the trial?

When did the trial start and what have we learned so far?

How does my participation in the I-SPY 2 Trial help other patients?

Why is the trial called the I-SPY 2 Trial?


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

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

Does taking the extra time to treat the tumor before surgery (neoadjuvant
therapy) pose any risk to me?

Drug treatment, drug assignments, and side effects

What investigational drugs are being tested in the trial?

How likely am I to receive one of the investigational drugs on the I-SPY 2 Trial?

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

What are the possible side effects of treatment?

Can I choose which treatment I receive?

Can I switch investigational drugs during the Treatment Phase of the I-SPY 2 Trial?

Are there any investigational drugs being tested specifically for patients with
HR+/HER2- MammaPrint low risk breast cancer?

Testing procedures and access to results

How many times will tissue be collected, and how will the tissue be collected?

What tests will be run on my tumor tissue and blood samples and will I know
the results?

How many times will my blood be collected?

How can we tell if the drug is working to shrink my tumor?

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

The I-SPY 2 Trial is sponsored by Quantum Leap Healthcare Collaborative, a 501(c)(3) charitable organization integrating high-impact clinical research with patient care.