Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
A Pragmatic Phase II Trial of Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests standard chemotherapy alone versus chemotherapy with a tocilizumab biosimilar, a drug made to closely match tocilizumab. It is for Black and non-Black adults with triple-negative or ER-positive, HER2-negative breast cancer that has spread or has come back and cannot be cured with local treatment. Patients are assigned to a treatment group by chance.
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab biosimilar in Black and non-Black patients with metastatic triple negative and ER-positive, HER2-negative breast cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and able to sign consent and health privacy forms.
- Have triple-negative or ER-positive, HER2-negative breast cancer that has spread or returned and cannot be cured with local treatment. These labels describe proteins found on cancer cells.
- For triple-negative cancer: have had no more than 2 treatments for cancer that has spread. Some patients must have had immune therapy, which helps the immune system fight cancer; exceptions apply.
- For ER-positive, HER2-negative cancer: have had hormone therapy plus a CDK inhibitor, a drug that slows cancer cell growth, and no more than 3 chemotherapy treatments for cancer that has spread. For either cancer type, chemotherapy given around surgery counts toward the limit if cancer returns during it or within 12 months after it.
- Plan to receive standard chemotherapy. Have cancer that can be measured and be fully active or able to do light work.
- Have liver, kidney, and blood test results that meet the study's limits.
- If cancer has spread to the brain or spinal cord, treatment must have ended more than 4 weeks ago. It must be stable and cause no symptoms, with steroid doses stable or decreasing. Known brain spread requires a brain scan.
- If able to become pregnant, have a negative pregnancy test within 14 days before joining. Men and women able to become pregnant must agree to effective birth control during treatment and for 6 months afterward.
Who can't join
- Past treatment with tocilizumab biosimilar or other drugs targeting IL-6 or its receptor, or a medical reason these drugs are unsafe for you.
- An active infection needing antibiotics given by injection or through a vein.
- Current methotrexate or steroid medicines that act throughout the body, except stable or decreasing steroid doses for cancer in the brain or spinal cord.
- Active cancer in the brain or spinal cord, or cancer there that causes symptoms.
- HER2-positive breast cancer, meaning cancer cells have high levels of the HER2 protein or extra copies of its gene.
- Another active cancer besides breast cancer. A past cancer that has not returned after standard treatment does not rule you out.
- Radiation or hormone therapy within 2 weeks before joining.
- Planned treatment with olaparib or another PARP inhibitor, a type of cancer drug.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (7)
GA
- Emory University · Atlanta, GA 30322Carlos Aguilera, BA · Study contact · 404-778-1868 · winshipcto@emory.eduShipra Gandhi, MD · Principal investigatorMore trials in Atlanta
IN
- IU Health Joe and Shelly Schwarz Cancer Center · Carmel, IN 46032Xin Bryan, RN · Study contact · 317-274-5495 · zhongx@iupui.eduMore trials in Carmel
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indianapolis, IN 46202Xin Bryan, RN · Study contact · 317-274-5495 · zhongx@iupui.eduKathy Miller, MD · Principal investigatorMore trials in Indianapolis
- Sidney and Lois Eskenazi Hospital · Indianapolis, IN 46202Xin Bryan, RN · Study contact · 317-274-5495 · zhongx@iupui.eduMore trials in Indianapolis
KY
- University of Kentucky-Lexington · Lexington, KY 40506Rayli Pichardo, MD · Study contact · 859-257-2862 · rcpi226@uky.eduAmanda Cavinder, BS · Study contact · 859-562-0539 · Amanda.Cavinder@uky.edu;More trials in Lexington
NC
- Duke University · Durham, NC 27708Samantha Womack, BA · Study contact · 919-660-1278 · sam.womack@duke.eduAlexandra Thomas, MD · Principal investigatorMore trials in Durham
NY
- Roswell Park Comprehensive Cancer Center · Buffalo, NY 14203Lindsay Moshides, MS · Study contact · 716-854-1300 ext. 6328 · Lindsay.Moshides@RoswellPark.orgSheheryar Kabraji, MD · Principal investigatorMore trials in Buffalo