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

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.

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 II
Enrollment Status