Metastatic Breast CancerPhase 2NCT05846789
Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
A Phase 2 study testing SOC Chemotherapy and Tocilizumab/Tocilizumab Biosimilar in people with Metastatic Breast Cancer and Triple Negative Breast Cancer, run by Kathy Miller at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer
- What is being tested?
- SOC Chemotherapy and Tocilizumab/Tocilizumab Biosimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Jul 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- 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)
- For patients with TNBC
- Received up to 2 prior therapies for metastatic disease
- 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.
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- Patients with TNBC whose tumors are PD-L1+ (CPS > 10) must have had prior exposure to an immune checkpoint inhibitor in the metastatic setting.
- 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.
- Patients with major contraindications to immune therapy, may participate without IO exposure regardless of PD-L1 status in the first line setting.
- PD-L1 status is not required for patients beyond the first line setting.
- Participation in this protocol as either first, second and third-line therapy is allowed
- For patients with ER- positive, HER2-negative breast cancer
- 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.
- May have received up to 3 prior chemotherapies for metastatic disease.
- 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.
- Participation in this protocol as either first, second, third, or fourth-line therapy is allowed
- Planned standard of care chemotherapy based on NCCN guidelines.
- Single agent therapy is preferred but use of combination regimens considered SOC by NCCN is allowed.
- Chemotherapy delivered via a SOC antibody-drug conjugate is allowed but ADCs may not be used in combination with other chemotherapy agents.
- Measurable disease based on RECIST 1.1 criteria.
- ECOG PS 0 or 1
- 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.
- Adequate organ function as indicated by:
- Total bilirubin < ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5.0 x ULN
- Creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula
- Absolute neutrophil count (ANC) > 1.2 K/mm3
- Platelets > 75 K/ mm3
- Hgb > 9.0 g/dL
- 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:
- Has undergone a hysterectomy or bilateral oophorectomy; or
- Has been naturally amenorrheic for at least 24 consecutive months.
- 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).
Who cannot join
- Prior treatment with or known contraindication to treatment with tocilizumab biosimilar or other IL-6/IL-6R targeted agent
- Active infection requiring parenteral antibiotics
- Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement
- Active or symptomatic CNS disease
- 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.
- Patients with active malignancy other than breast cancer. Patients with prior malignancies without recurrence after standard treatment will not be excluded
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- Radiation therapy within 2 weeks of registration
- Hormone therapy within 2 weeks of registration
- Planned treatment with Olaparib or other PARP inhibitor.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Carlos Aguilera, BA, 404-778-1868, winshipcto@emory.edu
Shipra Gandhi, MD
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Lindsay Moshides, MS, 716-854-1300 ext. 6328, Lindsay.Moshides@RoswellPark.org
Sheheryar Kabraji, MD
- Recruiting
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Xin Bryan, RN, 317-274-5495, zhongx@iupui.edu
- Recruiting
Duke University
Durham, North Carolina, 27708
Samantha Womack, BA, 919-660-1278, sam.womack@duke.edu
Alexandra Thomas, MD
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Xin Bryan, RN, 317-274-5495, zhongx@iupui.edu
Kathy Miller, MD
- Recruiting
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Xin Bryan, RN, 317-274-5495, zhongx@iupui.edu
- Recruiting
University of Kentucky-Lexington
Lexington, Kentucky, 40506
Rayli Pichardo, MD, 859-257-2862, rcpi226@uky.edu
Amanda Cavinder, BS, 859-562-0539, Amanda.Cavinder@uky.edu;
About this study
Official title: A Pragmatic Phase II Trial of Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
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.
Read the detailed description
Randomized phase II using a one-stage design. Patients are randomized 1:1 to either the monotherapy or combination arms. This requires 42 patients (21 per treatment arm) for each race-based cohort. All the calculations are based on Smart-Design-Indiana at https://iusccc.shinyapps.io/SmartDesign-Indiana/.
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer, ER Positive, HER2 Negative Breast Cancer
- Being tested
- SOC Chemotherapy, Tocilizumab/Tocilizumab Biosimilar
- Keywords
- Breast Cancer, Phase II
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC ChemotherapyDrug
SOC Chemotherapy will be given AUC 6 IV q3 weeks for a maximum of 9 infusions.
Tocilizumab/Tocilizumab BiosimilarDrug
Tocilizimab/Tocilizumab Biosimilar 8 mg/ actual body weight in kg IV q4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Black Monotherapy | Active comparator | Not described Receives: Drug: SOC Chemotherapy |
| Black Combination treatment | Experimental | Not described Receives: Drug: SOC Chemotherapy; Drug: Tocilizumab/Tocilizumab Biosimilar |
| Non-Black Monotherapy | Active comparator | Not described Receives: Drug: SOC Chemotherapy |
| Non-Black Combination treatment | Experimental | Not described Receives: Drug: SOC Chemotherapy; Drug: Tocilizumab/Tocilizumab Biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: through study completion (i.e. up to 2 years)
Efficacy of tocilizumab biosimilar in Black and non-Black patients
efficacy defined as using the difference in difference approach across race based cohorts
Measured: through study completion (i.e. up to 2 years)
Progression-free survival
Measured: through study completion (i.e. up to 2 years)
Secondary outcomes (3)
Safety of SOC chemotherapy monotherapy compared to SOC chemotherapy combined with tocilizumab/tocilizumab biosimilar using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
Measured: through study completion (i.e. up to 2 years)
Evaluate the differences in inflammatory pathways between Black and non-Black patients
Tumor PZP, IL-6, and phosphoSTAT3
Measured: Baseline
Evaluate the impact of Duffy genotype on efficacy in Black patients
Tumor PZP, IL-6, and phosphoSTAT3 between Duffy-null, Duffy-heterozygous, and Duffy-wild type
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start2 Jul 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are stratified by either Black or non-Black (race-based cohort) and are then randomized 1:1 to either the monotherapy or combination arm. This requires 42 patients (21 per treatment arm) in stage I for each race-based cohort. If the no. of response in experimental - no. of response in control is no greater than -1, the trial is early stopped at stage I for futility. Otherwise, additional 42 patients for each race-based cohort will be enrolled and randomized to the study in stage II for a total of 168 subjects across all 4 arms.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathy Miller
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor-investigator, Kathy Miller, Indiana University
- Investigators
- Kathy Miller, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846789
- Sponsor's protocol ID
- CTO-IUSCCC-0817
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Phase II Trial of Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
- ClinicalTrials.gov ID
- NCT05846789
- Acronym / sponsor ID
- CTO-IUSCCC-0817
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer, ER Positive, HER2 Negative Breast Cancer
- Keywords
- Breast Cancer, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Kathy MillerUniversity, hospital or other
- Collaborators
- Genentech, Inc., Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized phase II using a one-stage design. Patients are randomized 1:1 to either the monotherapy or combination arms. This requires 42 patients (21 per treatment arm) for each race-based cohort. All the calculations are based on Smart-Design-Indiana at https://iusccc.shinyapps.io/SmartDesign-Indiana/.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients are stratified by either Black or non-Black (race-based cohort) and are then randomized 1:1 to either the monotherapy or combination arm. This requires 42 patients (21 per treatment arm) in stage I for each race-based cohort. If the no. of response in experimental - no. of response in control is no greater than -1, the trial is early stopped at stage I for futility. Otherwise, additional 42 patients for each race-based cohort will be enrolled and randomized to the study in stage II for a total of 168 subjects across all 4 arms.
| Arm | Type | Receives |
|---|---|---|
| Black Monotherapy | Active comparator | Drug: SOC Chemotherapy |
| Black Combination treatment | Experimental | Drug: SOC Chemotherapy, Drug: Tocilizumab/Tocilizumab Biosimilar |
| Non-Black Monotherapy | Active comparator | Drug: SOC Chemotherapy |
| Non-Black Combination treatment | Experimental | Drug: SOC Chemotherapy, Drug: Tocilizumab/Tocilizumab Biosimilar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- 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)
- For patients with TNBC
- For patients with ER- positive, HER2-negative breast cancer
Key exclusion criteria (9 listed)
- Prior treatment with or known contraindication to treatment with tocilizumab biosimilar or other IL-6/IL-6R targeted agent
- Active infection requiring parenteral antibiotics
- Concurrent use of methotrexate or systemic corticosteroids other than stable or decreasing doses for management of CNS involvement
- Active or symptomatic CNS disease
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOC ChemotherapySOC Chemotherapy will be given AUC 6 IV q3 weeks for a maximum of 9 infusions. | Drug | Black Combination treatment, Black Monotherapy, Non-Black Combination treatment, Non-Black Monotherapy |
| Tocilizumab/Tocilizumab BiosimilarTocilizimab/Tocilizumab Biosimilar 8 mg/ actual body weight in kg IV q4 weeks | Drug | Black Combination treatment, Non-Black Combination treatment |
Primary outcome
Overall response rate
Time frame: through study completion (i.e. up to 2 years)
Efficacy of tocilizumab biosimilar in Black and non-Black patients
Time frame: through study completion (i.e. up to 2 years)
efficacy defined as using the difference in difference approach across race based cohorts
Progression-free survival
Time frame: through study completion (i.e. up to 2 years)
3 secondary outcomes
Safety of SOC chemotherapy monotherapy compared to SOC chemotherapy combined with tocilizumab/tocilizumab biosimilar using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
Time frame: through study completion (i.e. up to 2 years)
Evaluate the differences in inflammatory pathways between Black and non-Black patients
Time frame: Baseline
Evaluate the impact of Duffy genotype on efficacy in Black patients
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathy Miller, MD principal investigator
Indiana University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOC Chemotherapy and Tocilizumab/Tocilizumab Biosimilar in people with Metastatic Breast Cancer and Triple Negative Breast Cancer, run by Kathy Miller at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Bryan, RN (317-274-5495, zhongx@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: through study completion (i.e. up to 2 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.