Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer
Phase 1/2
Terminated
NCT04331067
| Condition | Triple Negative Breast Cancer |
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| Phase | Phase 1/2 |
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| Sponsor | Washington University School of Medicine |
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| Status | Terminated |
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| Enrollment | 15 participants |
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| Interventions | Paclitaxel, Carboplatin, Nivolumab, Cabiralizumab, Tumor biopsy |
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| Start date | Nov 19, 2020 |
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| Completion date | Mar 20, 2023 |
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| Results posted | May 16, 2024 |
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Summary
Prior to Amendment #7: The hypothesis of this study is that the combination of cabiralizumab and nivolumab with neoadjuvant chemotherapy will decrease tumor associated macrophages (TAMs) and increase tumor infiltrating lymphocytes (TIL) compared to neoadjuvant chemotherapy plus nivolumab in patients with early stage triple-negative breast cancer (TNBC) and improve clinical outcomes. As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. The hypothesis of this study is that on-treatment tumor associated macrophages (TAMs) and tumor infiltrating lymphocytes (TILs) will improve (reduced TAMs, increased TILs) following neoadjuvant nivolumab with chemotherapy.
Percent Change in Tumor Infiltrating Lymphocytes (TILs)
Baseline and week 5 · percent change
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | 95.2 ± 121 percent change |
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| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | 1.63 ± 82.5 percent change |
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Percent Change in Tumor Associated Macrophages (TAMs)
Baseline and week 5 · percent change
| Arm A and Unrandomized Arm: Neoadjuvant Chemo + Nivolumab | 31.8 ± 32.1 percent change |
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| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | -38.7 ± 63.6 percent change |
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Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only)
From start of treatment through 100 days after last day of study treatment or surgery whichever occurs first (approximately 16 weeks) · Participants
| Arm A: Neoadjuvant Chemo + Nivolumab | 4 Participants |
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| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | 2 Participants |
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| Arm A: Neoadjuvant Chemo + Nivolumab | 2 Participants |
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| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | 4 Participants |
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| Arm A: Neoadjuvant Chemo + Nivolumab | 1 Participants |
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| Arm B: Neoadjuvant Chemo + Nivolumab + Cabiralizumab | 0 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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