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

NCT05846789 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTO-IUSCCC-0817
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 6

Brief Summary

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

Metastatic Breast Cancer; Triple Negative Breast Cancer; Estrogen-receptor-low Breast Cancer

Keywords

Breast Cancer; Phase II

Outcome Measures

Primary Outcomes (3)

• Overall response rate

  through study completion (i.e. up to 2 years)

• Efficacy of tocilizumab in Black and non-Black patients

  efficacy defined as using the difference in difference approach across race based cohorts

  through study completion (i.e. up to 2 years)

• Progression-free survival

  through study completion (i.e. up to 2 years)

Secondary Outcomes (3)

• Safety of SOC chemotherapy monotherapy compared to SOC chemotherapy combined with tocilizumab using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0

  through study completion (i.e. up to 2 years)

• Evaluate the differences in inflammatory pathways between Black and non-Black patients

  Baseline

• Evaluate the impact of Duffy genotype on efficacy in Black patients

  Baseline

Study Arms (4)

Black Monotherapy

ACTIVE COMPARATOR

Drug: SOC Chemotherapy

Black Combination treatment

EXPERIMENTAL

Drug: SOC Chemotherapy; Drug: Tocilizumab

Non-Black Monotherapy

ACTIVE COMPARATOR

Drug: SOC Chemotherapy

Non-Black Combination treatment

EXPERIMENTAL

Drug: SOC Chemotherapy; Drug: Tocilizumab

Interventions

SOC Chemotherapy DRUG

SOC Chemotherapy will be given AUC 6 IV q3 weeks for a maximum of 9 infusions.

Black Combination treatment; Black Monotherapy; Non-Black Combination treatment; Non-Black Monotherapy

Tocilizumab DRUG

Tocilizimab 8 mg/ actual body weight in kg IV q4 weeks

Black Combination treatment; Non-Black Combination treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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-low (ER and PR ≤ 9% weak staining)
• Received up to 2 prior therapies for metastatic disease
• Prior (neo)adjuvant therapy 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 and third-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 agents.
• Patients with tumors that 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 in the second line setting.
• Measurable disease based on RECIST 1.1 criteria.
• Disease amenable to and consent for study-specific biopsy NOTE: If no disease amenable to biopsy is present at the time of second biopsy, subjects may continue participation in the study and further study specific biopsies will not be required.

You may not qualify if:

• Prior treatment with or known contraindication to treatment with tocilizumab 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
• Radiation therapy within 2 weeks of registration
• Hormone therapy within 2 weeks of registration
• Planned treatment with Olaparib or other PARP inhibitor.

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• Susan G. Komen Breast Cancer Foundation: collaborator
• Kathy Miller: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (6)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kathy Miller, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Bryan, RN

CONTACT

317-274-5495; zhongx@iupui.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ballvé-Lantero Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: July 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (6)