Breast tictoc Pragmatic:Phase2 of chemo+/- Tocilizumab in TNBC and ER-low Breast Cancers - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Adults with metastatic triple negative or Estrogen Receptor (ER)-low breast cancer

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

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, MD, FACP
Medical Oncologist
Protocol Number
IRB: PRO00118487
NCT: NCT05846789
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Support Duke Health research or honor a loved one with a tribute gift.
Giving to Duke Health