Sponsor:
Kathy Miller
Code:
NCT05846789
Conditions
Metastatic Breast Cancer
Triple Negative Breast Cancer
Estrogen-receptor-low Breast Cancer
ER Positive, HER2 Negative Breast Cancer
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
SOC Chemotherapy
Tocilizumab/Tocilizumab Biosimilar
Brief summary:
Conditions
Metastatic Breast Cancer
Triple Negative Breast Cancer
Estrogen-receptor-low Breast Cancer
ER Positive, HER2 Negative Breast Cancer
Study ID
NCT05846789
Start date
Jul 2, 2024
Status verified date
Sep, 2026
Completion date
Dec, 2027
Anticipated
Primary completion date
Dec, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
168 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
active comparator: Black Monotherapy
experimental: Black Combination treatment
active comparator: Non-Black Monotherapy
experimental: Non-Black Combination treatment
Interventions
SOC Chemotherapy
Tocilizumab/Tocilizumab Biosimilar
Primary outcome measure
Central contacts
Locations
Emory University
Recruiting
Atlanta, Georgia, United States, 30322
Contacts
Principal Investigator:
Shipra Gandhi, MD
IU Health Joe and Shelly Schwarz Cancer Center
Recruiting
Carmel, Indiana, United States, 46032
Contacts
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Recruiting
Indianapolis, Indiana, United States, 46202
Contacts
Principal Investigator:
Kathy Miller, MD
Sidney and Lois Eskenazi Hospital
Recruiting
Indianapolis, Indiana, United States, 46202
Contacts
University of Kentucky-Lexington
Recruiting
Lexington, Kentucky, United States, 40506
Contacts
Roswell Park Comprehensive Cancer Center
Recruiting
Buffalo, New York, United States, 14203
Contacts
Principal Investigator:
Sheheryar Kabraji, MD
Duke University
Recruiting
Durham, North Carolina, United States, 27708
Contacts
Principal Investigator:
Alexandra Thomas, MD
Sponsor
Kathy Miller
Last update posted
Sep 3, 2026
Last verified
Sep, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kathy Miller on 2026-09-03.