Cardiac monitoring with echocardiogram and tissue doppler imaging (TDI) and serum biomarkers to assess for cardiotoxicity with anthracyclines in women during adjuvant chemotherapy for breast cancer.

Southern Health0 个研究点目标入组 60 人开始时间: 2009年6月23日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Histologically or cytologically proven invasive adenocarcinoma of the breast.
•2.Early stage breast cancer T1-T4, any N Mo considered suitable for adjuvant chemotherapy.
•3.Planned to receive at least 3 cycles of anthracycline based chemotherapy.
•4.Age > 18 years.
•5.Karnofsky Performance status index > 80%.
•6.Routine laboratory requirements (within 28 days prior to registration):
•Haematology:
•- Neutrophils > 1.5 x 109/L
•- Platelets >100 x 109/L
•- Haemoglobin > 10 g/dL.
•Hepatic function:
•- Total bilirubin < 1 Upper Normal Limit (UNL) (patients with a well documented history of Gilbert’s Syndrome are eligible)
•- Aspartate transaminase (ASAT, SGOT) and AAlanine transaminase (ALAT, SGPT) < 2.5 UNL
•- Alkaline phosphatase < 5 UNL.
•Renal function:
•- Creatinine < 175 micro mol/L (2 mg/dL).
•7.Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
•8.Written informed consent.

•1.Prior or concurrent systemic anticancer therapy for breast cancer (immunotherapy, hormone therapy, biological, or chemotherapy).
•2.Prior or concurrent radiation therapy for breast cancer.
•3.Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
•4.M1 breast cancer.
•5.Serious cardiac medical condition including but not limited to: Congestive Heart Failure; unstable angina pectoris; previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or high-risk uncontrolled arrhythmias.
•6.Other serious illness or medical condition including but not limited to: active uncontrolled infection; active peptic ulcer; unstable diabetes mellitus; dementia or seizures that would prohibit the understanding of giving informed consent;
•7.History of significant neurological or psychiatric disorders including psychotic disorders.
•8.Current history of any neoplasm other than breast carcinoma.
•9.Concurrent treatment with other experimental drugs.
•10.Known allergy reactions or excipients used in the study.
•11.Male patients.

发起方

Southern Health