Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
The purpose of this study is to determine whether the addition of nivolumab to chemotherapy improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Indiana University
Bloomington, Indiana, United States
NYU Langone Health
New York, New York, United States
Number of Participants Who Had a Pathological Complete Response (pCR)
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Time frame: up to 16 weeks
Number of Participants Who Had a Pathological Complete Response (pCR)
pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).
Time frame: up to 1 year
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Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m\^2 on Day 1 of every 21 day cycle (Cycle 1-4)
Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4