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Could an arthritis drug help fight tough breast cancers?

NCT ID NCT05846789

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Durham, North Carolina, 27708, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • IU Health Joe and Shelly Schwarz Cancer Center

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Sidney and Lois Eskenazi Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • University of Kentucky-Lexington

    RECRUITING

    Lexington, Kentucky, 40506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.