A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers
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.
Detailed description
Randomized phase II using a two-stage Bayesian optimal phase II two-arm design (BOP2). Patients are randomized 1:1 to either the monotherapy or combination arms. This requires 42 patients (21 per treatment arm) in stage I for each race-based cohort. If the no. of response in experimental - no. of response in control is no greater than -1, the trial is early stopped at stage I for futility. Otherwise, additional 42 patients for each race-based cohort will be enrolled and randomized to the study in stage II.
Arms & 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
Outcome measures
Primary
Overall response rate
Time frame: through study completion (i.e. up to 2 years)
Efficacy of tocilizumab in Black and non-Black patients
efficacy defined as using the difference in difference approach across race based cohorts
Time frame: through study completion (i.e. up to 2 years)
Progression-free survival
Time frame: through study completion (i.e. up to 2 years)
Secondary
Safety of SOC chemotherapy monotherapy compared to SOC chemotherapy combined with tocilizumab using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
Time frame: through study completion (i.e. up to 2 years)
Evaluate the differences in inflammatory pathways between Black and non-Black patients
Time frame: Baseline
Evaluate the impact of Duffy genotype on efficacy in Black patients
Time frame: Baseline
Eligibility criteria
Study locations (6)
Emory University
Atlanta, Georgia, 30322
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Duke University
Durham, North Carolina, 27708