Description:
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Completed
Phase 2
Drug | Synonyms | Arms |
---|---|---|
Nivolumab 360mg | HER2-negative, including TNBC or HR-positive | |
Paclitaxel 80mg/m^2 | HER2-negative, including TNBC or HR-positive | |
Doxorubicin 60mg/m^2 | HER2-negative, including TNBC or HR-positive | |
Cyclophosphamide 600mg/m^2 | HER2-negative, including TNBC or HR-positive | |
Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2 | HER2-positive, independent of HR status | |
Trastuzumab 8mg/kg and 6 mg/kg | HER2-positive, independent of HR status | |
Pertuzumab 840mg and 420mg | HER2-positive, independent of HR status |
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).
Name | Type | Description | Interventions |
---|---|---|---|
HER2-negative, including TNBC or HR-positive | Experimental |
| |
HER2-positive, independent of HR status | Experimental |
|
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 |
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). |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | NYU Langone Health |
June 8, 2021