Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- 1-year Progression free survival (PFS)
研究概览
简要总结
Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies
详细描述
Several factors are thought to influence the variability of treatment efficacy and toxicity, including organ function, comedications, hormonal status, body weight, age, comorbidities, etc. Among them, single nucleotide polymorphisms (SNPs) as rs1128503, rs2032583 are attracting huge interest to address the interindividual variability in drug response, whether in terms of efficacy or safety
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years).
- •Confirmed diagnosis with MBC.
- •HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.
- •Patients with primary or secondary resistance to endocrine therapy.
- •Patients with Eastern Cooperative Oncology Group (ECOG) 0 or
- •Scheduled to receive Palbociclib in first- or second-line metastatic setting.
排除标准
- •Prior exposure to fulvestrant or everolimus.
- •Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
- •Patients refusing to sign the written informed consent.
研究组 & 干预措施
Primary resistant to endocrine therapy
Primary endocrine resistance is defined as a relapse within 2 years of adjuvant endocrine treatment or disease progression during the first 6 months of first-line endocrine therapy for advanced or MBC
干预措施: Palbociclib (Drug)
Secondary resistant to endocrine therapy
Secondary resistance is defined in early BC as a relapse that occurs after at least 2 years of endocrine therapy and during or within the first year of completing adjuvant endocrine therapy. In advanced BC or MBC, secondary resistance is defined as disease progression after more than 6 months of endocrine therapy
干预措施: Palbociclib (Drug)
结局指标
主要结局
1-year Progression free survival (PFS)
时间窗: 1 year
the time from enrollment until first evidence of disease progression or death
次要结局
- Neutropenia(1 year)
研究者
Yassmin Genina
Assistant lecturer at Faculty of Pharmacy
Helwan University