ACTRN12609000504213
Recruiting
未知
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 sites60 target enrollmentJune 23, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Southern Health
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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