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
For more information about who can join this study, please contact the study team at 919-660-1278.
- 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
For more information about who can join this study, please contact the study team at 919-660-1278.
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?
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
After you finish your study regimen, we will call you every 3 months for 1 year to see how you are doing.
- 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
After you finish your study regimen, we will call you every 3 months for 1 year to see how you are doing.
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
Susan
Dent
Protocol Number
PRO00103624
NCT ID
NCT03971409
Phase
II
Enrollment Status
OPEN TO ACCRUAL