EUCTR2017-001467-20-SE
Active, Not Recruiting
Phase 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 sitesJune 22, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Women with newly diagnosed breast cancer who are expected to receive neo-adjuvant or adjuvant therapy.
- Sponsor
- Dept. of Oncology, Karolinska university hospital
- Status
- Active, Not Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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