Phase II Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- pathologic complete response (pCR) in the breast and the axilla
研究概览
简要总结
Molecular expression in breast cancer (BC) defines special fenotypes with different prognostic and predictive features.Since the addition of trastuzumab and lapatinib to chemotherapy, HER2 overexpressing tumors have become the best responders to systemic therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A) or early distant relapse after diagnosis (triple negative BC) . In this open, prospective, non-randomized and multicentric phase II study the investigators include stage II and III HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with autologous dendritic cells pulsed with their own tumor. The hypothesis is that the reinforcement of the immune system with the autologous dendritic cell vaccination against HER2 negative BC could increase pathologic complete responses (pCR) and disease free survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance schedule.
详细描述
Chemotherapy schedule:
- dose dense epirubucin 100 mgr/m2 plus ciclofosfamide 600 mgr/m2 every two weeks for four cycles with with GM-CSF support on day +1 (pegylated filgastrim) or on days +5 to +9 (filgastrim) subcutaneously
- docetaxel 80-100 mgr/m2 every three weeks for four cycles. Addition of GM-CSF if docetaxel doses are > 85 mgr/m2
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HER2 negative and stage II and III Breast cancer patients who benefit with neoadjuvant chemotherapy
- •age 18-75
- •to get enough tumoral sample to elaborate the vaccine
排除标准
- •pregnancy
- •severe diseases
- •hepatitis or HIV
- •need to be on immunosuppressant drugs
结局指标
主要结局
pathologic complete response (pCR) in the breast and the axilla
时间窗: 6 months after starting chemotherapy
次要结局
- Number of participants with adverse events(During the 6-24 months of administration of the vaccine)
- Impact of the vaccine on patients DFS and OS(three to five years after the diagnosis of breast cancer)
- EORTC quality of life(From 9 months and up to two years)
- Correlation among the specific immune response induced in patients and the pathologic response of the tumor(6-24 months)
研究者
Marta Santisteban
MD, PhD
Clinica Universidad de Navarra, Universidad de Navarra