An Observational, Prospective Cohort Study, on Blood Coagulation Parameters in Postmenopausal Patients With Operable Breast Cancer Who Are Treated as Per Standard Practice With Adjuvant Hormonal Therapy for a Total of 5 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Percentage change (%) from baseline of the blood coagulation parameters (fibrinogen, PT, aPTT) at 6, 12, 18, and 24 months of treatment.
研究概览
简要总结
The objective of the study is to monitor the changes of blood coagulation parameters in postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5 years. The values of the standard coagulation parameters throughout the study will be compared with the baseline values.
详细描述
Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently discontinued for other reasons. The choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or radiotherapy. Percentage change (%) from baseline of the blood coagulation parameters at 6, 12, 18, and 24 months of treatment. The blood coagulation parameters which will be measured are fibrinogen, prothrombin time (PT) and activated partial thromboplastin time (aPTT).
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal status. ER and/or PgR status positive. Adjuvant hormonal treatment for 5 years according to standard practice has been decided by the treating physician. Values within normal limits for the blood coagulation parameters at baseline visit. Accessible for follow-up for the duration of the trial. Written informed consent.
排除标准
- •Both ER and PgR negative primary tumor. Evidence of distant metastases (M1) Neo-adjuvant hormonotherapy. Chronic use of oral anticoagulants such as warfarin or acenocoumarol. Psychiatric disorders preventing proper informed consent. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin.
结局指标
主要结局
Percentage change (%) from baseline of the blood coagulation parameters (fibrinogen, PT, aPTT) at 6, 12, 18, and 24 months of treatment.
时间窗: 2 years
次要结局
未报告次要终点
研究者
Markopoulos Christos
Professor of Surgery, Athens University Medical School
Hellenic Breast Surgeons Society