Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With Second-line Monochemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 149
- 试验地点
- 29
- 主要终点
- Definitive deterioration at 6 months
研究概览
简要总结
Post-authorization, prospective follow-up, multi-centre, national study to estimate definitive deterioration in the quality of life in patients with metastatic breast cancer treated with second-line monochemotherapy.
详细描述
Post-authorization, prospective, multi-centre study in Metastatic Breast Cancer patients treated with second-line monochemotherapy.
A total of 200 patients are expected to be recruited from 32 Spanish sites.
In this study the results perceived by patients will be compiled to assess overall Quality of Life (QoL) in MBC patients treated with second-line monochemotherapy, using the EORTC QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) and its modules EORTC QLQ-BR23 (EORTC Breast Cancer specific) and EORTC QLQ-CIPN20 (EORTC Chemotherapy-Induced Peripheral Neuropathy).
Patients will be evaluated at the time of acceptance to participate in the study after signing the informed consent and will be tracked every three months during treatment with second-line monochemotherapy, coinciding with routine assessments within normal clinical practice. When the patient completes treatment with second-line chemotherapy he/she will enter the post-treatment period, with follow-up at six and 12 months after completion of treatment. Also, patients will be followed to assess survival until the end of the study (30 months after enrolment of the last patient in the study). Follow-up time has been established based on the median survival of patients with MBC
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
- •Patients who give their written informed consent.
- •Patients with metastatic breast cancer who start treatment with second-line monochemotherapy.
- •Patients of both sexes, at least 18 years of age and of any race.
- •Patients with life expectancy longer than or equal to 12 weeks.
- •Patients with histological or cytological diagnosis of Her-2/neu negative breast adenocarcinoma.
- •Patients with ability enough to understand the questionnaires.
排除标准
- •Pregnant or lactating women.
- •Patients who have been treated with chemotherapy in the last three weeks
- •Patients who refuse to participate in the study.
结局指标
主要结局
Definitive deterioration at 6 months
时间窗: 6 months
Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC
次要结局
- Definitive deterioration at 3 months(3 Months)
- Definitive deterioration at 9 months(9 Months)
- Definitive deterioration at 12 months(12 Months)
- Time to Definitive deterioration (TTDD)(Up to 42 months)
- Overall survival(Up to 42 months)
- TTDD as a prognostic factor(Up to 42 months)
- Quality of life(Up to 42 months)
- Quality of life every 3 months(Up to 42 months)
- Chemotherapy-induced peripheral neuropathy(Up to 42 months)
- Chemotherapy-induced peripheral neuropathy in the EORTC QLQ-CIPN20(Up to 42 months)
- Definitive deterioration(Up to 42 months)