NCT03742986已完成2 期
Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had a Pathological Complete Response (pCR)
研究概览
简要总结
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
HER2-negative, including TNBC or HR-positive
Experimental
干预措施: Nivolumab 360mg (Drug)
HER2-negative, including TNBC or HR-positive
Experimental
干预措施: Paclitaxel 80mg/m^2 (Drug)
HER2-negative, including TNBC or HR-positive
Experimental
干预措施: Doxorubicin 60mg/m^2 (Drug)
HER2-negative, including TNBC or HR-positive
Experimental
干预措施: Cyclophosphamide 600mg/m^2 (Drug)
HER2-positive, independent of HR status
Experimental
干预措施: Nivolumab 360mg (Drug)
HER2-positive, independent of HR status
Experimental
干预措施: Doxorubicin 60mg/m^2 (Drug)
HER2-positive, independent of HR status
Experimental
干预措施: Cyclophosphamide 600mg/m^2 (Drug)
HER2-positive, independent of HR status
Experimental
干预措施: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2 (Drug)
HER2-positive, independent of HR status
Experimental
干预措施: Trastuzumab 8mg/kg and 6 mg/kg (Drug)
HER2-positive, independent of HR status
Experimental
干预措施: Pertuzumab 840mg and 420mg (Drug)
结局指标
主要结局
Number of Participants Who Had a Pathological Complete Response (pCR)
时间窗: 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).
次要结局
未报告次要终点
研究者
研究点 (2)
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