Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT03742986

Run by

NYU Langone Health

People needed

8

Starts

2019-05-02

Expected to finish

2023-06-12

Last updated by the study team

2023-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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)

Where it is running

• Indiana University — Bloomington, Indiana, United States
• NYU Langone Health — New York, New York, United States

Full record on ClinicalTrials.gov

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