A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers
Kathy Miller
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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-low (ER and PR ≤ 9% weak staining) 4. Received up to 2 prior therapies for metastatic disease 1. Prior (neo)adjuvant therapy 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. 2. Participation in this protocol as eith…
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 UniversityAtlanta, Georgia
- IU Health Joe and Shelly Schwarz Cancer CenterCarmel, Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana
- Sidney and Lois Eskenazi HospitalIndianapolis, Indiana
- Roswell Park Comprehensive Cancer CenterBuffalo, New York
- Duke UniversityDurham, North Carolina