Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: Nivolumab 360mg; Paclitaxel 80mg/m^2; Doxorubicin 60mg/m^2; Cyclophosphamide 600mg/m^2; Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2; Trastuzumab 8mg/kg and 6 mg/kg; Pertuzumab 840mg and 420mg
Intervention description: 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); 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
Intervention MeSH terms: Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Nivolumab; Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nivolumab

Summary:

      Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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)