Chemotherapy with or without Tocilizumab for Metastatic Breast Cancer

This study is for people with metastatic triple-negative or ER-low (estrogen receptor-low) breast cancer. It compares standard chemotherapy alone to standard chemotherapy combined with a drug called tocilizumab. Tocilizumab is an antibody that targets certain pathways in the body. Researchers will look at how many patients respond to the treatment, how long patients live without their cancer growing, and how well tocilizumab works in Black and non-Black patients. You may be able to join if you are 18 or older, have metastatic triple-negative or ER-low breast cancer, and have received up to two prior treatments for metastatic disease. The study is currently recruiting 168 participants.

Study design
This is a randomized Phase II study. Participants will be randomly assigned to receive either standard chemotherapy alone or standard chemotherapy with tocilizumab.
What's involved
Standard chemotherapy will be given every three weeks for up to nine infusions. Tocilizumab will be given every four weeks. The study will follow your progress for up to two years.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed through study completion, which is up to two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05846789

SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers

Recruiting
PHASE2Ages 18+InterventionalTreatment
Kathy Miller
~168 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:SOC ChemotherapyTocilizumab

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate
Measured over through study completion (i.e. up to 2 years)
+2 more outcomes measured
Metastatic Breast Cancer
Triple Negative Breast Cancer
Estrogen-receptor-low Breast Cancer
6 sites across 4 states
Indiana3
Georgia1
New York1
North Carolina1
  • Kathy Miller, MD · PRINCIPAL_INVESTIGATOR · Indiana University

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  • Overall response ratethrough study completion (i.e. up to 2 years)
  • Efficacy of tocilizumab in Black and non-Black patientsthrough study completion (i.e. up to 2 years)

    efficacy defined as using the difference in difference approach across race based cohorts

  • Progression-free survivalthrough study completion (i.e. up to 2 years)