Observational Study Evaluating the Efficacy and Tolerability of Anticancer Drug Therapies Adopted for the Treatment of Gynecologic and Breast Cancers in Clinical Practice Compared with the Results of Registration Studies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.
详细描述
This is a single-center retrospective/prospective observational study. Objective of the study is to evaluate the effect of drugs in terms of objective responses, disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and side effects compared with registry studies in the medical therapy of breast and gynecologic cancers.
Regarding the prospective component of the study, it is clarified that therapy will be warranted by clinical practice regardless of study enrollment. Diagnostic investigations will also be conducted as per normal practice; enrollment in the study does not require additional examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Diagnosis of histologically confirmed breast cancer or gynecological cancer, either early stage or metastatic;
- •Patients who have received treatment for breast cancer or gynecologic cancer since January 2010;
- •Any patient currently living and actually contactable must sign an informed consent to the study and processing of personal data.
排除标准
- •no exclusion criteria
研究组 & 干预措施
retrospective cohort
In this cohort data will be recorded retrospectively
干预措施: Oncologic drugs administered for treatment of breast cancer (Drug)
retrospective cohort
In this cohort data will be recorded retrospectively
干预措施: Oncologic drug administered for treatment of gynecologic cancer (Drug)
prospective cohort
In this cohort data will be recorded prospectively
干预措施: Oncologic drugs administered for treatment of breast cancer (Drug)
prospective cohort
In this cohort data will be recorded prospectively
干预措施: Oncologic drug administered for treatment of gynecologic cancer (Drug)
结局指标
主要结局
DFS
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 60 months.
To evaluate effect of drugs in terms of objective responses compared with registrational studies in medical therapy of breast and gynecological cancers: disease-free survival (DFS)
次要结局
- PFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.)
- OS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.)
- Side effects(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.)