Overview
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Status:
Completed
Completed
Trial end date:
2021-01-05
2021-01-05
Target enrollment:
0
0
Participant gender:
All
All
Summary
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBCPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
New York University School of Medicine
NYU Langone HealthTreatments:
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin
Nivolumab
Paclitaxel
Pertuzumab
Trastuzumab
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)