Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Overview
- Phase
- Phase 2
- Intervention
- Nivolumab 360mg
- Conditions
- Breast Cancer
- Sponsor
- NYU Langone Health
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Number of Participants Who Had a Pathological Complete Response (pCR)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Investigators
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
Arms & Interventions
HER2-negative, including TNBC or HR-positive
Intervention: Nivolumab 360mg
HER2-negative, including TNBC or HR-positive
Intervention: Paclitaxel 80mg/m^2
HER2-negative, including TNBC or HR-positive
Intervention: Doxorubicin 60mg/m^2
HER2-negative, including TNBC or HR-positive
Intervention: Cyclophosphamide 600mg/m^2
HER2-positive, independent of HR status
Intervention: Nivolumab 360mg
HER2-positive, independent of HR status
Intervention: Doxorubicin 60mg/m^2
HER2-positive, independent of HR status
Intervention: Cyclophosphamide 600mg/m^2
HER2-positive, independent of HR status
Intervention: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2
HER2-positive, independent of HR status
Intervention: Trastuzumab 8mg/kg and 6 mg/kg
HER2-positive, independent of HR status
Intervention: Pertuzumab 840mg and 420mg
Outcomes
Primary Outcomes
Number of Participants Who Had a Pathological Complete Response (pCR)
Time Frame: up to 1 year
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).