Purpose of this Study
This study has three parts:
1. Getting Ready (Screening)
- Takes up to 28 days
- You'll get blood tests, a tissue sample, a TB test, and health checkups like scans and heart tests.
2. Treatment (Study Dosing)
- People are grouped by race
- You'll be randomly picked to get either regular chemo or chemo plus a study medicine (tocilizumab)
- Medicine is given every 4 weeks
- You'll keep doing health checkups and answer questions.
3. After Treatment (Follow-up)
- Happens within 30 days after your last dose
- More health checkups and questions to see how you're doing.
Who Can Participate?
Eligibility
Who can join the study?
Adults with a certain kind of advanced breast cancer called metastatic triple negative or ER-low can join if they:
- Have had zero or one chemo treatment for their cancer
- Have cancer that doctors can measure
- Are healthy enough to do daily activities (rated as ECOG 0 or 1)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
Why is this study happening?
Doctors want to see if using two medicines together—tocilizumab and regular chemotherapy—works better than just using chemotherapy alone.
They are testing this in Black and non-Black patients who have a certain kind of advanced breast cancer.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Pragmatic Phase II Trial of Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers
Principal Investigator
Alexandra
Thomas
Protocol Number
PRO00118487
NCT ID
NCT05846789
Phase
II
Enrollment Status
Pending Open to Enrollment