TBCRC 047: InCITe (Breast Cancer) - Clinical Trial

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
Medical Oncologist
Protocol Number
IRB: PRO00103624
NCT: NCT03971409
Phase II
Enrollment Status
Open for Enrollment