I-SPY 2 TRIAL (Breast Cancer)

What is the Purpose of this Study?

We are doing this study to analyze biomarker responses to different drug regimens used for people who have HER2- and HER2+ breast cancer. We hope what we learn from the study can help us develop better treatments and figure out which treatment option(s) will be best for breast cancer patients.

What is the Condition Being Studied?

Breast Cancer

Who Can Participate in the Study?

Adults ages 18-90 who:

  • Are diagnosed with HER2+ and HER2- breast cancer
  • Have stage II or III disease

For more information about who can join this study, please contact the study team at sam.womack@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment to 1 of several different drug regimens for your cancer. These regimens contain experimental drugs, approved drugs, and/or a mix of experimental and approved drugs.

The study team will let you know before you decide to proceed what drug regimens might be assigned to you before you decide to take part. We will keep in touch with you for up to 5 years after you finish your drug regimen in the study.

Study Details

Full Title
I-SPY 2 Trial: Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2
Principal Investigator
Assistant Professor of Medicine
Protocol Number
IRB: PRO00116204
NCT: NCT01042379
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF