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

NYU Langone Health

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Trastuzumab 8mg/kg and 6 mg/kg; Drug: Cyclophosphamide 600mg/m^2; Drug: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2; Drug: Paclitaxel 80mg/m^2; Drug: Pertuzumab 840mg and 420mg; Drug: Doxorubicin 60mg/m^2; Drug: Nivolumab 360mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03742986

17-00890

Details and patient eligibility

About

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

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

HER2-negative, including TNBC or HR-positive

Experimental group

Treatment:

Drug: Nivolumab 360mg

Drug: Cyclophosphamide 600mg/m^2

Drug: Paclitaxel 80mg/m^2

Drug: Doxorubicin 60mg/m^2

HER2-positive, independent of HR status

Experimental group

Treatment:

Drug: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2

Drug: Nivolumab 360mg

Drug: Cyclophosphamide 600mg/m^2

Drug: Trastuzumab 8mg/kg and 6 mg/kg

Drug: Pertuzumab 840mg and 420mg

Drug: Doxorubicin 60mg/m^2