EUCTR2017-001467-20-SEActive, not recruitingPhase 1
Effects of Identifying and Treating Early, Subclinical Cardiotoxicity on the Long- Term Incidence of Clinical Cardiotoxicity in Women with Breast Cancer, a prospective randomised study: The Cardio-Oncology Breast Cancer Study. - COBC
Dept. of Oncology, Karolinska university hospital0 sitesStarted: June 22, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Women with newly diagnosed breast cancer who are eligible to receive neo-adjuvant or adjuvant chemotherapy, with or without trastuzumab, according to the guidelines for breast cancer.
- •Written informed consent must be given.
- •The participants can be included in other non-competing ongoing trilas.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
Exclusion Criteria
- •A history of heart disease; ischemic heart disease, arrhythmias, heart failure, and valve diseases.
- •Previously received oncological treatment for any malignancy.
- •Other disease or conditions that complicates or precludes the patient from following the study protocol.
- •Patients in child-bearing age without adequate contraception.
Investigators
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