Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers

NCT05846789 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Tocilizumab
  • DRUG SOC Chemotherapy

Study Locations (6)

Indiana

  • IU Health Joe and Shelly Schwarz Cancer Center — Carmel
  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
  • Sidney and Lois Eskenazi Hospital — Indianapolis

Georgia

  • Emory University — Atlanta

New York

  • Roswell Park Comprehensive Cancer Center — Buffalo

North Carolina

  • Duke University — Durham

Trial Details

FieldValue
Enrollment Target 168 participants
Start Date 2024-07-02
Est. Completion 2026-12
Phase Phase 2

Sponsor

Kathy Miller

2 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05846789

The ClinicalTrials.gov registry entry for NCT05846789 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kathy Miller, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Tocilizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05846789 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Indiana, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05846789 about?

NCT05846789 is a clinical study titled "SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers". 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.

What is the current status of trial NCT05846789?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2024-07-02. Estimated completion is 2026-12.

What conditions does trial NCT05846789 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05846789?

The interventions under investigation include: Tocilizumab (DRUG), SOC Chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05846789?

This trial is sponsored by Kathy Miller, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05846789 being conducted?

This trial has 6 study locations across Georgia, Indiana, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial