TBCRC 047: InCITe (Breast Cancer)

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.

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
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.

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
ClinicalTrials.gov