SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers (NCT05846789) | Clinical Trial Compass
RecruitingPhase 2
SOC Chemotherapy +/- Tocilizumab for Triple Negative and ER-low Breast Cancers
United States168 participantsStarted 2024-07-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 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.
Exclusion criteria
✕. 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
What they're measuring
1
Overall response rate
Timeframe: through study completion (i.e. up to 2 years)
2
Efficacy of tocilizumab in Black and non-Black patients
Timeframe: through study completion (i.e. up to 2 years)
3
Progression-free survival
Timeframe: through study completion (i.e. up to 2 years)
✕. 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