Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Investigator will evaluate the patients and treatment characters in counts and percentage of developing high-grade neutropenia induced by palbociclib.
研究概览
简要总结
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. To evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years PFS and OS.
详细描述
Palbociclib is an orally active cyclin-dependent kinase (CDK) and is considered the standard treatment for hormone receptor (HR)-positive, (HER) negative metastatic breast cancer.
The PALOMA studies' showed improvement in progression-free survival (PFS) compared to endocrine therapy alone but a non-significant trend towards improved overall survival (OS).
MONALEESA and MONARCH suggest significantly improved OS with the addition of CDK inhibition.
Neutropenia is considered the dose-limiting and most frequent adverse effect of CDK inhibitors resulting in frequent dose reductions and treatment interruptions that are potentially associated with a lack of efficiency. Grade III/IV neutropenia rates were 62-66% in the PALOMA studies.
Some studies investigated the risk factors for the development of palbociclib-induced neutropenia. One concluded that no concomitant use of statins and high BMI were identified as significant predictors for the development of palbociclib-induced neutropenia. and another study also concluded that low baseline ANC, WBC, PLT, and BSA were associated with early grade III/IV neutropenia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological pathological confirmation of primary breast cancer or metastatic disease.
- •Hormonal receptor-positive, HER2 negative.
- •Metastatic breast cancer at presentation (Den novo) or recurrent.
- •Patients did not receive any previous systemic therapy for metastatic disease.
- •Performance status (ECOG) 0-2.
排除标准
- •Patient with co-morbidity
- •Pregnant and breast lactating women
研究组 & 干预措施
1
cases developed neutropenia Grade 0-2 with palbociclib administration
干预措施: Palbociclib (Drug)
2
cases developed neutropenia Grade 3-4 with palbociclib administration
干预措施: Palbociclib (Drug)
结局指标
主要结局
Investigator will evaluate the patients and treatment characters in counts and percentage of developing high-grade neutropenia induced by palbociclib.
时间窗: 2 years
Investigator will record the patients and treatment characters in counts and percentage that associated with the occurrence of high-grade neutropenia. And then will compare the characters differences in patients with and without high grade neutropenia by uninitiated and multivariate statistical analysis.
assess treatment outcome as a progression free survival for palbociclib in patient with neutropenia
时间窗: 2 years
Measure the progression free survival
assess treatment outcome as overall survival for palbociclib in patient with neutropenia
时间窗: 2 years
Measure the overall survival
次要结局
未报告次要终点
研究者
Asmaa I Mekkawy
Principal Investigator
Assiut University