Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer

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.

NCT Number	NCT04331067
Lead Sponsor	Washington University School of Medicine Collaborators: Bristol-Myers Squibb
Conditions	Triple Negative Breast Cancer
Enrollment	15 participants
Start Date	2020-11-19
Primary Completion	2023-03-20 (estimated)
Study Completion	2026-06-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-09