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

NCT05846789 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-05-08

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Kathy Miller

    lead OTHER

Principal Investigators

  • Kathy Miller, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846789 on ClinicalTrials.gov