Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NYU Langone Health
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Newly diagnosed inflammatory breast cancer without distant metastases and have not received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed: Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and HER2-positive
You may not be if
Clinical or radiologic evidence of distant metastases
Malignancy that progressed within the last five years.
Cardiac disease (history of and/or active disease)
HIV positive
Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0
Allogeneic stem cell or solid organ transplantation
Autoimmune disease where in the opinion of the Investigator would preclude the use of immunotherapy
Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonitis
Tuberculosis
Pregnancy or lactation
Treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunosuppressive medications
Cardiopulmonary dysfunction
Clinically significant history of liver disease, including cirrhosis, autoimmune hepatic disorders, HIV infection, or active Hepatitis B or Hepatitis C
Subject is pregnant or nursing
Known hypersensitivity to the components of the study drugs(s)
