Kathy Miller
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab biosimilar in Black and non-Black patients with metastatic triple negative and ER-positive, HER2-negative breast cancer.
Randomized phase II using a one-stage design. Patients are randomized 1:1 to either the monotherapy or combination arms. This requires 42 patients (21 per treatment arm) for each race-based cohort. All the calculations are based on Smart-Design-Indiana at https://iusccc.shinyapps.io/SmartDesign-Indiana/.
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Locally recurrent (not amenable to local therapy with curative intent) or metastatic breast cancer that is triple negative or ER-positive (ER and PR ≤ 1% weak staining) 4. For patients with TNBC 1. Received up to 2 prior therapies for metastatic disease 2. Prior (neo)adjuvant chemotherapy will be considered one line of therapy for metastatic disease in patients who recur while on or within 12 months of completion of (neo)adjuvant therapy. 3.…
SOC Chemotherapy will be given AUC 6 IV q3 weeks for a maximum of 9 infusions.
Tocilizimab/Tocilizumab Biosimilar 8 mg/ actual body weight in kg IV q4 weeks