NCT05846789 · Kathy Miller
SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers
What this study is about
This is a randomly assigned Phase II study of the usual treatment (SOC) chemotherapy treatment given alone vs. SOC chemotherapy combined with tocilizumab in in Black and non-Black patients with metastatic triple negative or ER low breast cancer.
View original scientific description
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.
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
Primary outcome measures
Overall response rate
Time frame: through study completion (i.e. up to 2 years)
Efficacy of tocilizumab in Black and non-Black patients
Time frame: through study completion (i.e. up to 2 years)
efficacy defined as using the difference in difference approach across race based cohorts
Progression-free survival
Time frame: through study completion (i.e. up to 2 years)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 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. Zero or one prior chemotherapy for metastatic disease a. 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. 5. Planned standard of care chemotherapy based on NCCN guidelines. 1. Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed. 2. Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other agents. 6. Patients with tumors that are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setti
Where
- Atlanta, Georgia
- Carmel, Indiana
- Indianapolis, Indiana
- Buffalo, New York
- Durham, North Carolina
Collaborators
Genentech, Inc., Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations