Trials / Recruiting
RecruitingNCT05846789
SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers
A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- Sponsor
- Kathy Miller · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-07-02
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-05-06
- Last updated
- 2026-01-21
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05846789. Inclusion in this directory is not an endorsement.