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Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers

ConditionsMetastatic Breast CancerTriple Negative Breast CancerEstrogen-receptor-low Breast CancerER Positive, HER2 Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKathy Miller

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SOC Chemotherapy

    Drug

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

  • Tocilizumab/Tocilizumab Biosimilar

    Drug

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

Treatment groups

168 Participants
are divided into 4 treatment groups
Group A: Black MonotherapyActive comparator 1 intervention
Group B: Black Combination treatmentExperimental treatment 2 interventions
Group C: Non-Black MonotherapyActive comparator 1 intervention
Group D: Non-Black Combination treatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall response rate

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

Efficacy of tocilizumab biosimilar in Black and non-Black patients

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

Time frame
through study completion (i.e. up to 2 years)
3

Progression-free survival

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

Secondary outcomes

1

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)
2

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

Tumor PZP, IL-6, and phosphoSTAT3

Time frame
Baseline
3

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kathy Miller

Lead sponsor

Indiana University

Sponsor institution

Genentech, Inc.

Collaborator

Breast Cancer Research Foundation

Collaborator

Susan G. Komen Breast Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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