Prospective Construction and Validation of a Prognostic Score to Identify Among Patients With Metastatic Breast Cancer Those Who Benefit From a Third Line Chemotherapy in Terms of Overall Survival
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 16
- 主要终点
- Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
研究概览
简要总结
This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up.
This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer.
The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line.
This score will then be validated on the 2nd cohort.
There will be no interruption of inclusions between first and second cohort of patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Women of more than 18 years old
- •Metastatic breast cancer
- •Progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy
- •Evaluable disease
- •Histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and HER-2
- •Patient able to complete the EORTC PAL 15 Questionnaire
- •Patient member in a national insurance scheme
- •Informed consent obtained and signed by the patient
排除标准
- •History of other (s) cancer (s) potentially metastatic (s)
- •Woman participating in a third line chemotherapy clinical trial
- •Pregnant women or nursing mothers can not participate in the study
- •Patient under legal guardianship
- •Patient unable to undergo medical test for various reasons including social or psychological reasons.
结局指标
主要结局
Overall survival defined as the time from patient inclusion to the date of death or date of last follow-up news (censured data)
时间窗: 11 years
次要结局
- Oncologists satisfaction regarding the management and communication with the patient will be studied at baseline and at the time or progression using the Likert ordinal scale(7 years)
- Patient satisfaction regarding therapeutic decisions at inclusion using a specific questionnaire developed by Llewellyn-Thomas(11 years)
- The time to progression, defined as the time from patient inclusion to the date of the first documented tumor progression(11 years)
- Quality of life using the EORTC QLQ-C15-PAL Questionnaire(11 years)
- Regret or not of the patient to have followed a 3rd line of chemotherapy will be recorded at the end of the treatment using the "Decision regret scale" Questionnaire, established by A. O'Connor(11 years)
- Safety evaluated according to the classification of NCI CTCAE (Common Terminology Criteria for Adverse Events) V4.0(11 years)