Purpose of this Study
We are doing this study to find out if avelumab is a safe and effective option for triple negative metastatic breast cancer when it is combined with different anti-cancer drugs.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with metastatic triple negative breast cancer
- Have received no more than 2 lines of previous treatment for their cancer
- Have never been treated with sacituzumab govitecan
- Have not used more than one immunotherapy drug for their cancer
Age Range
18-89
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 (fair, equal chance) to 1 of 3 groups:
- One group will receive avelumab and liposomal doxorubicin
- One group will receive avelumab, liposomal doxorubicin, and binimetinib
- One group will receive avelumab with sacituzumab govitecan
- Have blood draws
- Have imaging scans
- Have heart scans (EKG and echocardiogram)
- Have biopsies
- Give us permission to store your tissue samples
- Answer questionnaires
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A multicenter, multi-arm Translational Breast Cancer Research Consortium study
Principal Investigator
Carey
Anders
Protocol Number
PRO00103624
NCT ID
NCT03971409
Phase
II
Enrollment Status
Open to Enrollment