Clinical Trials /

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

NCT03742986

Description:

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

Related Conditions:
  • Inflammatory Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
  • Official Title: Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)

Clinical Trial IDs

  • ORG STUDY ID: 17-00890
  • NCT ID: NCT03742986

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Nivolumab 360 mg+ paclitaxel 80 mg/m2HER2-negative, including TNBC or HR-positive
Doxorubicin 60 mg/m2+Cyclophosphamide 600 mg/m2HER2-negative, including TNBC or HR-positive
Nivolumab 360 mg+ Docetaxel* 75 mg/m2 +Trastuzumab 8 mg/kg +Pertuzumab 840 mgHER2-negative, including TNBC or HR-positive
Doxorubicin 60 mg/m2 +Cyclophosphamide 600 mg/m2HER2-negative, including TNBC or HR-positive

Purpose

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

Detailed Description

      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).
    

Trial Arms

NameTypeDescriptionInterventions
HER2-negative, including TNBC or HR-positiveExperimental
  • Nivolumab 360 mg+ paclitaxel 80 mg/m2
  • Doxorubicin 60 mg/m2+Cyclophosphamide 600 mg/m2
  • Nivolumab 360 mg+ Docetaxel* 75 mg/m2 +Trastuzumab 8 mg/kg +Pertuzumab 840 mg
  • Doxorubicin 60 mg/m2 +Cyclophosphamide 600 mg/m2
HER2-positive, independent of HRExperimental
  • Nivolumab 360 mg+ paclitaxel 80 mg/m2
  • Doxorubicin 60 mg/m2+Cyclophosphamide 600 mg/m2
  • Nivolumab 360 mg+ Docetaxel* 75 mg/m2 +Trastuzumab 8 mg/kg +Pertuzumab 840 mg
  • Doxorubicin 60 mg/m2 +Cyclophosphamide 600 mg/m2

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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in pathological complete response (pCR)
Time Frame:6 Years
Safety Issue:
Description: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).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:NYU Langone Health

Trial Keywords

  • Nivolumab

Last Updated