Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05846789

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

Led by Kathy Miller · Updated on 2026-05-08

168

Participants Needed

6

Research Sites

126 weeks

Total Duration

On this page

Sponsors

K

Kathy Miller

Lead Sponsor

G

Genentech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of consent
  • Able to provide written informed consent and HIPAA authorization
  • Locally recurrent or metastatic triple negative or ER-low breast cancer (ER and PR 4 9% weak staining)
  • Received up to 2 prior therapies for metastatic disease
  • Planned standard of care chemotherapy based on NCCN guidelines, including single agent or combination regimens
  • Patients with PD-L1+ tumors (CPS > 10) must have prior immune checkpoint inhibitor exposure in metastatic setting, with exceptions allowed
  • Measurable disease by RECIST 1.1 criteria
  • ECOG performance status 0 or 1
  • Treated, asymptomatic CNS disease allowed if stable and >4 weeks from CNS therapy completion
  • Adequate organ function including bilirubin, liver enzymes, creatinine clearance, neutrophils, platelets, and hemoglobin
  • Women of childbearing potential must have negative pregnancy test within 14 days of registration
  • Women of childbearing potential and men must agree to use effective contraception during and 6 months after treatment
Not Eligible

You will not qualify if you...

  • Prior treatment with or contraindication to tocilizumab or other IL-6/IL-6R agents
  • Active infection requiring IV antibiotics
  • Concurrent methotrexate or systemic corticosteroids other than stable or decreasing doses for CNS management
  • Active or symptomatic CNS disease
  • HER2 positive breast cancer
  • Active malignancy other than breast cancer
  • Radiation therapy within 2 weeks before registration
  • Hormone therapy within 2 weeks before registration
  • Planned treatment with PARP inhibitors such as Olaparib

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, United States, 46032

Actively Recruiting

3

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

4

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States, 46202

Actively Recruiting

5

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

Actively Recruiting

6

Duke University

Durham, North Carolina, United States, 27708

Actively Recruiting

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Research Team

X

Xin Bryan, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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