Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- CMR T2 mapping
研究概览
简要总结
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines* (decline of LVEF ≥10% points with a final LVEF <53%) measured on CMR and ECHO over the time window of 12 months from the end of radiation therapy.
详细描述
Overall study schedule The Overall Study Schedule is summarized in the assessment schedule (appendix 1).
This study is composed of three subsequent phases: a Run-In Phase, a RT/Systemic Therapy Phase, a Follow-Up Phase.
Run-In Phase The Run-In Phase starts with the first visit (before any cancer treatment), when Screening/Enrollment procedure is performed. This phase will start once a patient has provided WIC to participate in the study and ends the day of treatment start.
Screening / Enrolment Visit Visit will be performed before the expected starting date of treatment.
After a WIC has been obtained from the patient, the patient will be visited by the Investigators and the following information will be gathered:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed
- •Age ≥ 18 years at visit 1
- •Performance status ECOG 0-1
- •*Stage I-III histology proven breast cancer
- •Treated with adjuvant radiotherapy and neo/adjuvant anthracycline and/or trastuzumab-based therapy +/- hormonal therapy
- •Negative pregnancy test (plasma HCG) for all females of childbearing potential (i.e not permanently sterilised- post hysterectomy or tubal ligation status) In the ancillary study patients with stage 0 (DCIS) histology proven breast cancer will also be included.
排除标准
- •Known metastatic spread of any cancer
- •Known active or recurrent hepatic disorder (cirrhosis, hepatitis), ASAT/ALAT 2xULN
- •Renal function decrease (eGFR < 30 ml/min)
- •Known coronary artery disease
- •Angina pectoris
- •Positive or missing pregnancy test (pre- and perimenopausal women) at enrolment visit
- •Patients with baseline LVEF <53% and GLS <15%
- •Patients with pacemaker
结局指标
主要结局
CMR T2 mapping
时间窗: Time window of 12 months from the end of radiation therapy
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines\* (decline of LVEF ≥10% points with a final LVEF \<53%).
次要结局
- GLS(Time window of 12 months from the end of radiation therapy)
- Biomarkers (Troponine, pro-BNP, hs-CRP) correlate with LVEF(Time window of 12 months from the end of radiation therapy)
- Biomarkers (Troponine, pro-BNP, hs-CRP) correlated with GLS(Time window of 12 months from the end of radiation therapy)
- Biomarkers (Troponine, pro-BNP, hs-CRP) predictors of cardiotoxicity(Time window of 12 months from the end of radiation therapy)
- Major cardiovascular events(follow-up)
- acute asymptomatic pericarditis(through study completion, an average of 1 year)
- cardiac edema(through study completion, an average of 1 year)
- Myocardial edema(Time window of 12 months from the end of radiation therapy)
- Time to biomarkers (Troponine, pro-BNP, hs-CRP) increase(Time window of 12 months from the end of radiation therapy)
- cardiac fibrosis(through study completion, an average of 1 year)