RecruitingPhase 2NCT05846789

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

A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers


Sponsor

Kathy Miller

Enrollment

168 participants

Start Date

Jul 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding tocilizumab — a drug that reduces inflammation — to standard chemotherapy can improve outcomes for people with triple-negative or hormone receptor-low breast cancer that has spread or cannot be treated with surgery. **You may be eligible if...** - You are 18 or older - You have locally recurrent or metastatic breast cancer that is triple-negative or has very low hormone receptor expression - You have not previously received chemotherapy for advanced/metastatic disease - You are in good enough health to receive chemotherapy **You may NOT be eligible if...** - You have already received chemotherapy for metastatic breast cancer - You have uncontrolled brain metastases - You have a history of serious infections or immune system disorders - You are pregnant or breastfeeding - You have had prior treatment with a CDK4/6 inhibitor or certain other targeted therapies - You have significant heart, liver, or blood count problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSOC Chemotherapy

SOC Chemotherapy will be given AUC 6 IV q3 weeks for a maximum of 9 infusions.

DRUGTocilizumab

Tocilizimab 8 mg/ actual body weight in kg IV q4 weeks


Locations(6)

Emory University

Atlanta, Georgia, United States

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Duke University

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05846789


Related Trials