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RECRUITING
NCT05846789
PHASE2

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

Sponsor: Kathy Miller

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2024-07-02

Completion Date

2026-12

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

SOC Chemotherapy

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

DRUG

Tocilizumab

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