TBCRC 047: InCITe (Breast Cancer)
What is the 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.
What is the Condition Being Studied?
Metastatic Triple Negative Breast Cancer
Who Can Participate in the Study?
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.
Age Group
Adults
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
Regardless of group assignment, everyone in the study will:
- 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.
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
Professor of Medicine
Protocol Number
IRB:
PRO00103624
NCT:
NCT03971409
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
Participate
Call 919-660-1278