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.
Who Can Participate?
Eligibility
Adults ages 18-90 who:
- Are diagnosed with HER2+ and HER2- breast cancer
- Have stage II or III disease
Age Range
18-90
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Alexandra
Thomas
Protocol Number
PRO00116204
NCT ID
NCT01042379
Phase
II
Enrollment Status
Pending Open to Enrollment