CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i.
研究概览
简要总结
Breast cancer is one of the tumors with the highest incidence and current evidence indicates a higher prevalence in elderly patients (≥70 years) with a higher mortality rate due to immunosenescence, diagnostic delay and under treatment. Elderly patients are still poorly represented in clinical trials and the main indications for the treatment of the elderly population are extrapolated from the guidelines used in studies conducted predominantly on the younger population. In particular, these guidelines do not take into account the significant variability of elderly patients, in particular their comorbidities, performance status, physiological age and frailty.
The aim of this study is to improve understanding of the clinical efficacy and safety of CDK 4/6i in older women in a real-world setting compared to younger women.
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 over 18 years
- •patients with solid tumours undergoing active systemic treatment with CDK4/6 for adjuvant disease
排除标准
- •Patients who are unable to understand informed consent document
结局指标
主要结局
Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i.
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
The primary objective of this study will be to evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during CDK 4/6i administration. The primary endpoint will be the estimated incidence of toxicity (haematological and/or non-haematological) of any grade over a 12-month time window in elderly MBC and EBC patients (≥70 years) from our cohort of cancer patients treated with CDK 4/6i.
次要结局
- Compare the toxicity rate between elderly and young MBC subjects;(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Compare the rate of switch therapies between elderly and younger EBC subjects;(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Compare the rate of dose reductions between elderly and younger EBC subjects;(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Compare the invasive disease free survival (iDFS) between elderly and younger EBC subjects.(from the date of CDK 4/6i initiation to the date of first occurrence of ipsilateral invasive breast tumor recurrence, assessed up to 24 months)
研究者
Angioletta Lasagna
Oncologist
Fondazione IRCCS Policlinico San Matteo di Pavia