Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- RCB
研究概览
简要总结
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with age of 18 to 70 years old.
- •Newly diagnosed breast cancer patients.
- •Planned neoadjuvant chemotherapy.
- •Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.
- •HER2/neu-negative.
- •Ki67≥30%.
- •Clinical stage IIB-IIIC.
- •Informed consent form understood and signed.
- •Patient agrees to all follow-up visits.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Women of childbearing potential must have a negative serum pregnancy test.
排除标准
- •Metastatic disease
- •Pregnancy.
- •Nursing mothers.
- •Active or uncontrolled infection.
- •Presence of another malignancies.
- •Granulocyte count < 1.5*10^9/L.
- •Platelet count < 100*10^9/L.
- •Hemoglobin < 90g/L.
- •Serum Creatinine more than 1.5 upper limit.
- •AST and ALT more than 2.5 upper limit.
- •LVEF< 50%.
研究组 & 干预措施
dose-dense arm
干预措施: dose-dense nab-paclitaxel followed by EC (Drug)
结局指标
主要结局
RCB
时间窗: 7 days
Residual Cancer Burden
次要结局
未报告次要终点
研究者
Zhiyong Wu
Dr.
Shantou Central Hospital