An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- incidence of treatment-related neutropenia
研究概览
简要总结
This is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast cancer.
详细描述
An important advance in the use of dose dense chemotherapy regimens for breast cancer was the development of pegylated form of G-CSF (pegfilgrastim and lipegfilgrastim), which offered the convenience of single subcutaneous injection, rather than multiple daily injections
Lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim (G-CSF). In a pivotal randomized phase III study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim.
In this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support is being investigated.
Data will be collected on 40 consecutive patients treated with AC and lipegfilgrastim in Ireland.
The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Stage I-III Breast Cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1(see below)
- •Adequate Bone Marrow Function as defined by neutrophil count of ≥1.0 and platelet count of ≥ 100
- •Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) as deemed appropriate by a Consultant Medical Oncologist
- •General Indications for Dose Dense AC include:
- •T3 or T4 Tumours
- •N1 - N3 (Node Positive) Disease
- •Human Epidermal Growth Factor Receptor 2 (HER2) Positive Tumours.
- •Triple Negative Breast Cancer as evidenced by lack of expression of the estrogen receptor (ER), progesterone receptor (PR) and HER2
排除标准
- •Stage IV Breast Cancer
- •Previous Chemotherapy Exposure
- •Prior Exposure to G-CSF
- •Known positive HIV Status
- •Cardiac or other concurrent illness, which at the investigator's discretion contraindicates the use of AC
结局指标
主要结局
incidence of treatment-related neutropenia
时间窗: four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
次要结局
- incidence of febrile neutropenia(four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).)
- incidence of treatment-related neutropenia(Up to 1 year of subsequent chemotherapy)
研究者
Patrick Morris
Consultant Medical Oncologist
Beaumont Hospital