Could an arthritis drug help fight tough breast cancers?
NCT ID NCT05846789
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests whether adding tocilizumab, an anti-inflammatory drug, to standard chemotherapy improves outcomes for people with metastatic triple-negative or ER-low breast cancer. Researchers will compare the combination to chemotherapy alone in 168 Black and non-Black patients. The goal is to see if the drug shrinks tumors and slows cancer growth, while also exploring differences in inflammation between racial groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tocilizumab (a drug that blocks inflammation) combined with standard chemotherapy
- What this could lead to
- If it works, this could point toward a more effective treatment for hard-to-treat breast cancers, especially by reducing inflammation that may help tumors grow.
- What could go wrong
- This is an early phase II trial with only 168 participants, so results may not apply to everyone. Tocilizumab can increase infection risk, and the added benefit over chemo alone is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 168 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥ 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-positive (ER and PR ≤ 1% weak staining) 4. For patients with TNBC 1. Received up to 2 prior therapies for metastatic disease 2. Prior (neo)adjuvant chemotherapy 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. 3. Patients with TNBC whose tumors are PD-L1+ (CPS \> 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting. 4. Patients who received (neo)adjuvant IO therapy and progress while on or within 12 months of completion of (neo)adjuvant IO therapy may participate without additional IO treatment. 5. Patients with major contraindications to immune therapy, may participate without IO exposure regardless of PD-L1 status in the first line setting. 6. PD-L1 status is not required for patients beyond the first line setting. 7. Participation in this protocol as either first, second and third-line therapy is allowed 5. For patients with ER- positive, HER2-negative breast cancer 1. Must have received prior hormone therapy + CDKi in the adjuvant or metastatic setting. There is no limit on the number of prior hormone therapy regimens. 2. May have received up to 3 prior chemotherapies for metastatic disease. 3. Prior (neo)adjuvant chemotherapy 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. 4. Participation in this protocol as either first, second, third, or fourth-line therapy is allowed 6. 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 chemotherapy agents. 7. Measurable disease based on RECIST 1.1 criteria. 8. ECOG PS 0 or 1 9. Patients with treated, asymptomatic CNS disease may participate if the patient is \> 4 weeks from completion of CNS therapy (radiation and/or surgery), is clinically stable at the time of study entry, and is receiving stable or decreasing dose of corticosteroids. Brain MRI or head CT is required at screening for patients with known brain metastases. 10. Adequate organ function as indicated by: 1. Total bilirubin \< ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin \< 3.0 mg/dL) 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5.0 x ULN 3. Creatinine clearance of \> 50 mL/min using the Cockcroft-Gault formula 4. Absolute neutrophil count (ANC) \> 1.2 K/mm3 5. Platelets \> 75 K/ mm3 6. Hgb \> 9.0 g/dL 11. Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria: 1. Has undergone a hysterectomy or bilateral oophorectomy; or 2. Has been naturally amenorrheic for at least 24 consecutive months. 12. Women of childbearing potential and men must agree to use effective contraception throughout the study and for 6 months after the last study treatment. NOTE: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections). Exclusion Criteria: 1. Prior treatment with or known contraindication to treatment with tocilizumab biosimilar or other IL-6/IL-6R targeted agent 2. Active infection requiring parenteral antibiotics 3. Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement 4. Active or symptomatic CNS disease 5. Patients with HER2+ disease Note: HER2 will be considered positive if scored 3+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \> 2.0 or \> 6 total HER2 gene copies per cell. 6. Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be excluded 7. Radiation therapy within 2 weeks of registration 8. Hormone therapy within 2 weeks of registration 9. Planned treatment with Olaparib or other PARP inhibitor.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for ER positive/HER2 negative metastatic breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
7 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Duke University
RECRUITINGDurham, North Carolina, 27708, United States
-
Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
-
IU Health Joe and Shelly Schwarz Cancer Center
RECRUITINGCarmel, Indiana, 46032, United States
-
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITINGIndianapolis, Indiana, 46202, United States
-
Roswell Park Comprehensive Cancer Center
RECRUITINGBuffalo, New York, 14203, United States
-
Sidney and Lois Eskenazi Hospital
RECRUITINGIndianapolis, Indiana, 46202, United States
-
University of Kentucky-Lexington
RECRUITINGLexington, Kentucky, 40506, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to why some cancer treatments work better
- Unlocking TNBC survival: genetic clues from 3,648 women
- New drug targets Sugar-Coated proteins on cancer cells
- Can a blood test reveal when breast cancer treatment stops working?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Blood test aims to track cancer treatment response in real time